Quick facts
- United States: a dental cement is a named entry at 21 CFR 872.3275, and the section carries more than one class inside it.
- United States: zinc oxide eugenol cement is filed in that section under product code EMB in Class I, while a dental cement under product code EMA sits in Class II. The section title does not fix one class for every product inside it.
- Canada: the schedule does not name a dental cement, and the definition of "dental material" was repealed in 2002, so there is no definition to look the product up under.
- Canada: Rule 3(a) names only two categories of dental material — denture materials and orthodontic appliances, with their accessories — and places them in Class II.
- Canada: a cement that is neither of those is reached from the rule that matches its contact, and the invasive-device rule places a device that penetrates the body through a body orifice in Class II while reducing a device placed in the oral cavity as far as the pharynx to Class I.
- Canada: the regulation text cited here is current to 2026-09-21 and was last amended on 2026-06-17.
A cement cartridge looks the same in both countries, but the two systems behind it do not file it the same way. One names the cement and then splits the products inside the name; the other names no cement at all and reaches a class from a rule. For a dental buyer, that split decides what the order has to cite and what happens when a product is substituted for another cement.
What is a dental cement used for?
It is a material that holds a restoration in place or protects the tooth under it, and it is chosen for the job rather than for a single generic use.
The three jobs a cement is bought for are luting, which holds a crown, a bridge or an inlay to the preparation; lining, which protects the pulp under a restoration; and temporary sealing, which holds a dressing in place between visits. The chemistry changes with the job — zinc oxide eugenol, zinc phosphate, glass ionomer and resin-modified versions all sit in the same clinical family and not all of them sit in the same class.
That range is what the two systems describe differently. One keeps a family name and places the products inside it at different classes; the other does not use the family name at all.
| Item | Canada | United States |
|---|---|---|
| How a cement is described | No named entry | A named entry at 21 CFR 872.3275 |
| Class for zinc oxide eugenol cement | Reached from the rule matching contact | Class I, code EMB |
| Class for a general dental cement | Reached from the rule matching contact | Class II, code EMA |
| What a filing cites | The rule and the contact | The device entry and product code |
Why does one American section carry two classes?
Because the section names the cement family and the products inside it are filed at two different classes, and the code is what separates them.
21 CFR 872.3275 carries the title "Dental cement". Inside it, zinc oxide eugenol cement is filed under product code EMB in Class I, and a dental cement is filed under product code EMA in Class II. The section also carries a cement for ear, nose and throat use under a separate code, which shows how widely one title can reach. The class is therefore read from the code, not from the title.
What this means for a buyer is that "it is a dental cement" does not settle the class in the United States. The product code is the field that does, and a substitute that changes code can change the class without changing the clinical use.
| Cement type | US code | US class | Canadian rule to read | Canadian class |
|---|---|---|---|---|
| Zinc oxide eugenol cement | EMB | Class I | Contact rule for the product | Reached from contact |
| Dental cement, general | EMA | Class II | Contact rule for the product | Reached from contact |
| Cement for ear, nose and throat use | NEA | Class II | Not a dental rule | Outside this family |
How do Canada and the United States classify a dental cement?
It reaches a class from the rules, because there is no cement entry and no "dental material" definition left to look the product up under.
The classification schedule attached to the Medical Devices Regulations, SOR/98-282 names very few dental products. Rule 3(a) names two categories of dental material — denture materials and orthodontic appliances, with their accessories — and places them in Class II. A restorative cement is neither a denture material nor an orthodontic appliance, so Rule 3(a) does not reach it.
The definition that would have caught the product was removed. The regulations once defined "dental material" in the interpretation section, and that definition was repealed in 2002, so the term is no longer available as a lookup. A cement is therefore read against the rules that describe its contact: the invasive-device rule places a device that penetrates the body through a body orifice in Class II while reducing a device placed in the oral cavity as far as the pharynx to Class I, and the non-invasive catch-all places other non-invasive devices in Class I.
Do Canada and the United States reach the same class for a luting cement?
They can reach the same class by different routes, and they can also disagree. The American class comes from the product code inside the cement entry; the Canadian class comes from the rule that matches the product's contact and use.
A buyer comparing two cements therefore has two different questions to answer. In the United States the question is which code the product is filed under inside 21 CFR 872.3275. In Canada the question is which rule describes the contact — and because the schedule names no cement, the answer is carried in the rule text rather than in a product name.
The practical consequence is that the cement's intended contact has to be written on the order. A product used on a preparation and a product used as a temporary seal are not the same classification premise, and in Canada that field is what the class is read from.
What goes on the record for a cement?
The product, the code or the rule, the lot and the date, because a cement that cannot be traced is a restoration that cannot be explained.
- Keep the code with the product. In the United States the product code inside 872.3275 is what states the class, so it belongs on the order and on the stock sheet.
- Keep the rule with the product in Canada. Because no cement is named, the rule that matches the contact is the classification evidence, and it should sit with the product record.
- Record the lot and the working time. A cement has a working time and a set time, and a substitute with a different working time is a clinical change.
- Separate luting from temporary. The two jobs sit in the same family and not always in the same class, so a mixed drawer produces a mixed record.
- Write the intended contact. A restorative product and a temporary seal take different contact, and in Canada that is the field the class is read from.
Which consumables does a restorative operatory restock?
A restorative operatory runs on the isolation and barrier lines that sit beside the cement shelf. The 2 medium cotton rolls keep the field dry while a cement is placed, and the 3-layer paper and PE dental bibs cover the patient barrier. A practice that also runs its own steriliser pairs the sterilization monitoring collection with the biological indicator 5-pack trial. For clinics and multi-site groups buying at case level, the wholesale ordering page sets out account and case terms, and the B2B wholesale collection lists the lines held for institutional buyers. Reselling? become a distributor.
Sources
- 21 CFR 872.3275, dental cement
- 21 CFR 872.3200, resin tooth bonding agent
- 21 CFR 872.3250, calcium hydroxide cavity liner
- 21 CFR 872.3260, cavity varnish
- 21 CFR 872.3220, facebow
- 21 CFR 872.3165, precision attachment
- 21 CFR 872.4565, dental hand instrument
- Medical Devices Regulations, SOR/98-282
- ISO 4049:2019, polymer-based restorative materials
- ISO 6872:2015, dental ceramic
- ISO 13485:2016, medical device quality management
- ISO 14971:2019, risk management of medical devices
- openFDA device classification API
- Canadian Dental Association
- Royal College of Dental Surgeons of Ontario
- Ad Standards, non-prescription and cosmetic guidelines
- CCOHS, OSH answers
- Public Health Ontario, laboratory services test index
- CLSI, clinical and laboratory standards
- ISO 15189:2022, medical laboratories
A cement shelf whose record is missing is the same shelf that gets a substitution question. The printable dental luting log is a free sheet with columns for the product, the code or rule, the lot, the working time and the date, so a restorative record is written down rather than remembered. The luting log generator built for a single operatory sizes the sheet to the number of chairs a practice runs. No account and no sign-up are needed to open either one.
Where the class of a cement and the rule behind it need to be set out for a review, a written answer is worth more than a general one. Ask a compliance specialist and a written answer comes back specific to your equipment and province, with the regulation or standard it is based on cited.
Related reading
- Dental Amalgam in Canada vs the US: Which Class
- Dental Crown Materials in Canada vs the US: Which Material and Class
- Dental Impression Materials in Canada vs the US: Which Class
CliniEco Medical supplies laboratory, eye care 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 material and the records kept by a practice belong to the practice and to the requirements that apply to it.
Frequently Asked Questions
Is dental cement a Class I or a Class II device in the United States?
It can be either, because the class is read from the product code inside 21 CFR 872.3275. Zinc oxide eugenol cement is filed under code EMB in Class I, and a general dental cement is filed under code EMA in Class II.
Does Canada have a named entry for dental cement?
No. The schedule names no dental cement, and the definition of "dental material" was repealed in 2002, so there is no definition to look the product up under.
What does Rule 3(a) cover in Canada?
Rule 3(a) names denture materials and orthodontic appliances, and their accessories, and places them in Class II. A restorative cement is neither, so the rule does not reach it.
How is the class reached in Canada if no cement is named?
It is reached from the rule that matches the product's contact. The invasive-device rule places a device penetrating the body through a body orifice in Class II while reducing a device placed in the oral cavity as far as the pharynx to Class I, and the non-invasive catch-all places other non-invasive devices in Class I.
Why does the product code matter more than the title?
The title of 21 CFR 872.3275 is "Dental cement" and it carries more than one class inside it. The product code is the field that states which class applies, so a substitute that changes code can change the class.
What should a cement record carry?
The product, the code or the rule, the lot, the working time and the date, along with the intended contact. In Canada the rule and the contact are what the class is read from.
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