Quick facts
- A dental dam, also called a rubber dam, is a stretched sheet that isolates a tooth from saliva and keeps the working field dry.
- In the United States a rubber dam and its accessories are a named Class I entry at 21 CFR 872.6300, with product codes that cover the sheet, the clamp and the frame.
- In Canada a non-latex dam is a mechanical barrier and falls to Class I under Rule 4(2) of the Medical Devices Regulations; a dental instrument is also Class I under Rule 3(b).
- The latex or non-latex choice is a biocompatibility and allergy question, and the material is tested against ISO 10993-1:2018.
- The class is the same whether the sheet is latex or latex-free; what changes is the material, not the entry.
- The entries and rule text below were checked against the current eCFR text and the Regulations on 2026-10-07.
A dental dam is the sheet a clinician stretches over a tooth and holds with a clamp and a frame so that the tooth sits alone in the field. It keeps saliva, blood and debris away from the working area, keeps a rinse or an irrigant out of the patient's mouth, and protects the airway during work that produces small debris. The sheet is bought in boxes of pre-cut squares or as a roll, and the first decision a clinic makes is whether to buy latex or a latex-free material — a decision that is about the patient and the team rather than about the device class, which is the same either way.
What is a dental dam made of?
The common materials are natural rubber latex and the latex-free alternatives, usually nitrile or silicone. Latex stretches further and tears in a controlled way, which is why it has a long history in isolation. Latex-free sheets trade a little of that stretch for the absence of the proteins that cause latex allergy, and they are the default where a patient or a team member is sensitised.
| Property | Latex dam | Latex-free dam |
|---|---|---|
| Material | Natural rubber latex | Nitrile or silicone |
| Stretch and tear | High stretch; predictable tear | Lower stretch; firmer |
| Allergy risk | Contains latex proteins | No latex proteins |
| Where it is chosen | Where no one is sensitised | Where a patient or a clinician is sensitised |
| Class | Class I | Class I |
Why does latex-free matter?
Because latex allergy is a real and, in a dental setting, a repeat exposure. A sensitised patient or clinician who meets latex proteins can react, and the mouth is a place where a reaction is hard to manage. Many clinics run latex-free as the default rather than tracking who is sensitised, because the cost of a reaction is higher than the difference in the price of the sheet. The switch does not change the device class or the paperwork; it changes the material and the labelling, which is why the two are separate purchasing lines.
How do Canada and the United States treat a dental dam?
Both countries classify the dam, the clamp and the frame the same way. The material does not move the class.
| Item | Canada | United States |
|---|---|---|
| Named entry for the dam | None; a non-invasive mechanical barrier | 21 CFR 872.6300, rubber dam and accessories |
| Class of the dam | Class I under Rule 4(2), or Rule 7(1) | Class I |
| Clamp | Class I as a dental instrument | Product code under 872.6300, Class I |
| Frame | Class I as a dental instrument | Product code under 872.6300, Class I |
| Latex-free version | Same class; material differs | Same entry; material differs |
| Basis of the class | Intended use recorded for the device | The named entry it is filed under |
In the United States the openFDA device classification API lists 21 CFR 872.6300 for a rubber dam and accessories, and the entries under it sit at Class I. The product codes cover the sheet itself as EIE, the clamp as EEF and EJG, and the frame as EJE, which is why a single purchase order for a dam kit crosses three codes even though the class is the same. In Canada a dam is a non-invasive device used as a mechanical barrier, and under Rule 4(2) of the Medical Devices Regulations a device intended as a mechanical barrier, for compression or for absorption of exudations is classified as Class I. A dental instrument is separately placed in Class I by Rule 3(b).
Which standard covers the material?
Where a sheet touches tissue, the material is tested for biocompatibility. ISO 10993-1:2018 sets the biological evaluation of medical devices and is the standard a maker points to when asked how a material was assessed, and the manufacturing system behind it sits in ISO 13485:2016. The isolation practice itself is covered by the infection-control expectations of the provincial regulator, and in Ontario the Royal College of Dental Surgeons of Ontario sets those expectations, alongside the Canadian Dental Association and the Public Health Ontario guidance on infection prevention and control.
| Element | What the standard covers | Why it matters at the chair |
|---|---|---|
| Biocompatibility | Material assessment under ISO 10993-1 | A sensitised patient meets less of a known allergen |
| Manufacturing | Quality system under ISO 13485 | The sheet is made to a repeatable specification |
| Isolation practice | Infection-control expectations | The dam is part of moisture and aerosol control |
| Records | Device records where a device | A lot can be traced if a reaction is reported |
Which consumables sit with the dam on the tray?
An isolation setup is restocked as a set. The three-layer dental bibs cover the patient below the field, and the double-tipped cotton swabs handle the drying and prep that go with isolation. Where a clinic also runs its own steriliser, the sterilization monitoring collection pairs with the 24-hour monitoring five-pack trial. Clinics and multi-site groups ordering at case level use the wholesale ordering page, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
How is a dam placed and removed?
The sheet is stretched over the tooth, a hole is made for the tooth or the sheet is placed with a pre-cut opening, and the field is sealed with a clamp and held by a frame. Floss is often tied around the clamp as a safety line so that a clamp cannot be swallowed if it slips. At the end of the appointment the sheet is cut away and discarded, the clamp and frame are reprocessed under the clinic's instrument rules, and the field is checked before the patient leaves. The single-use sheet and the reusable clamp follow two different paths, which is another reason a purchase order that treats them as one item causes confusion at sterilisation.
Sources
- 21 CFR 872.6300, Rubber dam and accessories
- openFDA device classification API
- Medical Devices Regulations, SOR/98-282, full text and Schedule 1
- Health Canada, medical devices
- ISO 10993-1:2018, biological evaluation of medical devices
- ISO 13485:2016, medical devices quality management
- ISO 14971:2019, risk management of medical devices
- Royal College of Dental Surgeons of Ontario, standards and guidelines
- Canadian Dental Association
- American Dental Association, infection control and sterilization
- Public Health Ontario, infection prevention and control
- Public Health Ontario, infectious diseases
- ADA, science and research institute
- Standards Council of Canada
- CSA Group
- CCOHS, personal protective equipment
- US FDA, medical devices
- World Health Organization, oral health fact sheet
Where dam placement is recorded
A placement that is not recorded cannot be tied to a lot if a reaction is reported. The printable isolation and dam placement log is a blank sheet with columns for the patient, the tooth, the material, the lot and the date, so a latex-free placement and a latex placement are visible as separate lines. The isolation log generator on the same page sizes the sheet to the number of operatories a clinic runs. No account and no sign-up are needed to open either one.
Every operatory and every material range is different. Ask a compliance specialist and you will get a written answer specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Dental dams in Canada vs the US: materials and isolation
- Rubber dam clamps in Canada vs the US: which class
- Dental hand instruments in Canada vs the US: which class
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 procurement professionals and is not legal advice; the class of a device and the records kept by a clinic belong to the manufacturer and to the requirements that apply to it.
Frequently Asked Questions
Is a dental dam a Class I device?
Yes, in both countries. In the United States a rubber dam and accessories are named at 21 CFR 872.6300 at Class I, and in Canada a non-latex dam used as a mechanical barrier falls to Class I under Rule 4(2) of the Medical Devices Regulations.
Does a latex-free dam have a different class?
No. The class is the same whether the sheet is latex or latex-free. Only the material and the labelling change, not the entry or the rule that applies.
Why would a clinic choose latex-free dams?
Because latex allergy is a repeat exposure in a dental setting and a reaction is hard to manage in the mouth. Many clinics run latex-free as the default rather than tracking who is sensitised.
Which standard covers the material of a dam?
ISO 10993-1:2018 sets the biological evaluation of medical devices and is the standard a maker points to for material assessment, with the manufacturing system behind it in ISO 13485:2016.
What are the product codes for a rubber dam in the US?
A rubber dam sits under 21 CFR 872.6300. The sheet is code EIE, the clamp EEF and EJG, and the frame EJE. A dam kit can therefore cross three product codes at one class.
Are a dam and a clamp handled the same way?
No. The sheet is single use and is discarded after the appointment, while the clamp and frame are reused and reprocessed under the clinic's instrument rules.
Does the dam help with aerosol control?
It contributes. A dam isolates the tooth and limits what enters the mouth, and it is used alongside high-volume evacuation for moisture and aerosol control during procedures that generate spray.
Where should a dam placement be recorded?
The printable isolation and dam placement log at the compliance log centre has columns for the patient, tooth, material, lot and date, and the isolation log generator on the same page sizes the sheet to the number of operatories a clinic runs.
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