Quick facts
- A temporary crown and bridge resin is the material a practice uses to make a provisional crown, bridge or veneer that stays in place until the laboratory returns the permanent restoration.
- 21 CFR 872.3770 names it at Class II, with product codes EBG (temporary crown and bridge resin) and POW (long-term temporary) in the openFDA database.
- Canada has no entry. The material does not enter the body, so it is a non-invasive device and Rule 7(1) gives Class I; a material labelled for a denture or as an orthodontic accessory is an accessory to those devices and Rule 3(a) gives Class II.
- The two markets therefore disagree on the same jar: Class II by name in the United States, Class I by rule in Canada for a provisional crown, and Class II again in Canada if the label says denture.
- Setting time, wear resistance and colour stability are the clinical variables; the class is the purchasing variable that decides what paperwork the practice should hold.
- Text, classes and product codes were read on 2026-10-17; the Canadian rules were read from the consolidated Regulations the same day.
A provisional crown is the tooth-shaped placeholder a practice makes while the laboratory builds the real one: a resin cured in a matrix, trimmed at the chair and cemented for a few weeks. The American regulations name the material and put it in Class II; the Canadian schedule reaches Class I for the same jar because the material never enters the body, and only moves to Class II when the label ties it to a denture. This article sets out both readings, the handling and record items that go with a provisional, and the isolation consumables used at the same appointment, including the latex dental dam that keeps the field dry while the resin sets.
What is a temporary crown and bridge resin, and what is it for?
It is a polymer system - most often polymethylmethacrylate, a bis-acryl composite or a light-cured resin - supplied as a powder and liquid, a cartridge for an auto-mix tip, or a paste in a compule. The American identification text describes a device composed of a material such as polymethylmethacrylate, intended to make a temporary prosthesis such as a crown or bridge, for use until a permanent restoration is fabricated.
The clinical job has three parts: protect the prepared tooth, hold the space and the occlusion, and look acceptable for the weeks in between. Each part sets a material property. Protection needs a sealed margin; space and occlusion need dimensional stability and wear resistance; appearance needs colour stability and a polishable surface. A material that is easy to trim but chalky after a week fails the third requirement and comes back.
Provisionals are also a communication object. The shape the patient leaves with is the shape the laboratory is asked to copy, so a provisional that is refined chairside carries information the impression alone does not. That is why practices that make provisionals in house tend to keep a small inventory of shades rather than one universal shade.
What class is temporary crown and bridge resin in the United States?
21 CFR 872.3770 is the entry. The identification describes a material such as polymethylmethacrylate intended to make a temporary prosthesis for use until a permanent restoration is fabricated, and the classification is Class II. Unlike many entries in Part 872, this one carries no subparagraph splitting the class by variant.
The openFDA classification database returns EBG for temporary crown and bridge resin and POW for long-term temporary crown and bridge resin, both at Class II. The two codes track the intended wear period: a material described for a longer interim carries the second code, and a practice that uses one material for both short and long provisionals should know which description it bought.
| Item | United States | Detail |
|---|---|---|
| Regulation | 21 CFR 872.3770 | Temporary crown and bridge resin |
| Class | Class II | No sub-class split in the section |
| Product codes | EBG, POW | Temporary; long-term temporary |
| Stated use | Temporary prosthesis until a permanent restoration is made | PMMA given as the example material |
| Read on | eCFR identification and classification; openFDA codes | 2026-10-17 |
How does Canada classify the same resin?
Canada keeps no entry, and the analysis starts with contact. A crown resin is placed on a prepared tooth; it does not pass into tissue, it is not absorbed and it is not connected to an active device, so it is a non-invasive device. Rule 7(1) of Schedule 1 reads: "Subject to subrule (2), all other non-invasive devices are classified as Class I."
Two other clauses can change the answer. Rule 2(2) keeps a device that is placed in the oral cavity as far as the pharynx in Class I, which is the same result by a different route. Rule 3(a) is the one that moves the class: "all denture materials and orthodontic appliances, and their accessories, are classified as Class II." A resin described on its label as a denture reline, repair or rebase material is an accessory to a denture, and that sentence takes it to Class II.
The result is a class difference for a provisional crown - Class II in the United States and Class I in Canada - that reverses for a denture material, where both markets land in Class II. A practice that buys one resin for provisionals and another for chairside denture repairs is buying two different regulatory objects even when the jars look alike.
| Item | Canada | United States |
|---|---|---|
| Named entry | None; classified by rule | 21 CFR 872.3770 |
| Provisional crown use | Rule 7(1) - Class I | Class II |
| If described as placed in the oral cavity | Rule 2(2) - Class I | Class II |
| If described as denture material | Rule 3(a) - Class II | Different entry, Class II |
| Product code | Not applicable | EBG / POW |
Why does a Class I material need a Class II file in one market?
Because the class is a property of the market, not of the jar. A Canadian distributor of a Class I material holds the establishment obligations that go with importing a device, and the manufacturer holds the quality-system evidence; neither has to produce a device licence for a provisional resin. The same product sold into the United States sits in Class II and the manufacturer's file carries the premarket evidence that goes with that class.
For a practice the difference changes what to ask for. From a Canadian supplier, the reasonable request is the instructions for use in the required language, a statement of the material's intended use, and a lot number on the package. From a supplier selling across the border, the same request plus a statement of which market the unit was labelled for, because a US-labelled jar sold into Canada is a jar whose Canadian status nobody has documented.
None of this changes the clinical handling. It changes the file the practice keeps, and the file is what an inspection reads when it asks how the practice knows what it bought.
What should a practice check before buying a provisional resin?
The setting behaviour first. Working time at room temperature, because a material that sets in ninety seconds is a material for one tooth and not for a bridge; and the exotherm, because a large volume of resin in a matrix can warm the pulp. Both numbers belong in the technique sheet the practice keeps at the chair.
Then the service properties: wear resistance against the opposing tooth, colour stability over the intended wear period, and whether the material can be repaired or added to after it has set. A provisional that cannot be polished is a provisional that stains, and one that cannot be repaired is one that is remade.
| Specification | What to ask | Why it matters |
|---|---|---|
| Working time | Seconds at room temperature | Single tooth versus bridge |
| Set time | Seconds, and the exotherm | Chair time and pulp safety |
| Wear resistance | Stated for the interim period | Occlusal stability |
| Colour stability | Stated shade stability | Appearance over weeks |
| Repairability | Add-on or not after set | Chairside correction |
| Shades | Range stocked | Matching the case |
Material standards are the second layer. ISO 10477:2018 covers polymer-based crown and veneering materials and sets requirements for the properties a manufacturer claims; ISO 10993-1:2025 is the biological evaluation framework a Class II file rests on. A supplier who can name the standard behind a property claim is a supplier who has tested it.
How should the provisional be recorded?
The note should say the material, the shade, the cement and the date, because the removal appointment depends on all three. A provisional that fails early is a provisional whose material and cement are the first questions, and a practice that recorded only the tooth number has nothing to check.
The lot number belongs with the record as well, and it is the item practices drop first. A lot that is traced back from a failed batch is how a supplier's recall reaches the chair; without it the practice learns about the problem from the patient. The 3-layer paper and PE dental bibs, 500 per pack and the isolation items at the same appointment are stocked lines, but the resin lot is the record line that matters.
What is the difference between a temporary and a long-term temporary resin?
The intended wear period. A temporary resin is described for the weeks between preparation and cementation of the permanent restoration; a long-term temporary is described for a longer interim, and in the American scheme it carries its own product code, POW, rather than EBG. The material may be similar; the claim is not, and the claim is what the class and the code follow.
For a practice the distinction is a stocking decision. A long-term temporary is the material for a case that is waiting on a specialist, a healing period or a laboratory delay; a standard temporary is the material for the routine. Keeping only one of them means the other case is served by a material used outside its stated period, which is a documentation problem rather than a clinical one until the provisional fails.
An operatory that seats provisionals also reorders the bibs used at the same appointment. Order through the wholesale programme for case pricing and an account, or become a distributor for resale. The 3-layer paper and PE dental bibs, 500 per pack sits in the same catalogue. Consumables for this line are listed under the department page.
Sources
- 21 CFR 872.3770, temporary crown and bridge resin
- 21 CFR 872.3760, denture relining, repairing or rebasing resin
- 21 CFR 872.3690, tooth shade resin material (adjacent entry)
- openFDA device classification API
- FDA product classification database
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Health Canada, medical devices
- ISO 10477:2018, polymer-based crown and veneering materials
- ISO 10993-1:2025, biological evaluation of medical devices
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, application of risk management to medical devices
- ISO 17664-1:2021, processing of health care products
- Royal College of Dental Surgeons of Ontario, standards and guidelines
- Canadian Dental Association
- Public Health Ontario, infection prevention and control
- CCOHS, OSH answers
- Standards Council of Canada
Printable provisional record. A provisional that fails is a case that turns on what was written at the chair. Print a provisional crown record sheet - tooth, shade, material lot, cement and review date; it prints on plain paper with no account and no sign-up.
Log generator. Enter the material and the review interval and the page returns a dated chairside sheet. Build a provisional case sheet - the columns follow the order a chart review reads them, from tooth number to the permanent cementation date.
Ask a compliance specialist. Whether a resin is Class I or Class II in Canada turns on the intended use in its label, not on the jar. Ask a compliance specialist - written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Dental cements in Canada and the US: which class applies
- Cavity varnishes and liners in Canada and the US: which class applies
- Denture reline materials in Canada and the US: which class applies
CliniEco Medical supplies eye care, laboratory and dental consumables of the kind described in this article. MDEL #35334. This article is written for optometry, laboratory and dental procurement professionals and is not legal advice; the class of a device and the records a practice keeps belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
What class is temporary crown and bridge resin in the United States?
21 CFR 872.3770, Class II. Product codes are EBG for temporary resin and POW for long-term temporary resin.
What class is temporary crown and bridge resin in Canada?
Class I under Rule 7(1), because the resin is a non-invasive device. Rule 3(a) lifts a material labelled as a denture material or an orthodontic accessory to Class II.
Why is the Canadian class lower than the American one?
The American entry classifies the material by name at Class II. The Canadian schedule classifies by contact with the body, and a resin on a prepared tooth does not enter the body, so Rule 7(1) gives Class I.
Does a denture repair resin follow the same rule?
No. A resin described as a denture reline, repair or rebase material is an accessory to a denture, and Rule 3(a) makes it Class II in Canada.
What should a practice record when it seats a provisional?
The material, the shade, the lot number, the cement and the review date, alongside the tooth number. The lot is what links a failed provisional back to a batch.
What standard covers polymer-based crown materials?
ISO 10477:2018 sets requirements for polymer-based crown and veneering materials, and ISO 10993-1:2025 is the biological evaluation framework behind the material's biocompatibility file.
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