Written and maintained by CASRAI Editorial Board
Last updated
General product and regulatory information only. This page is not medical or dental advice and does not tell anyone which teeth to choose for a denture.
Short answer
Denture teeth are the prefabricated teeth set into a denture. In US regulation, plastic denture teeth and porcelain teeth are two separate device types: plastic teeth are Class II and exempt from 510(k) premarket notification subject to limitations (FDA product code ELM, 21 CFR 872.3590), while porcelain teeth are Class II with a 510(k) submission type (product code ELL, 21 CFR 872.3920).
Definition and scope
The Code of Federal Regulations defines a preformed plastic denture tooth as a prefabricated device, composed of materials such as methyl methacrylate, that is intended for use as a tooth in a denture (21 CFR 872.3590(a)).
A porcelain tooth is defined as a prefabricated device made of porcelain powder for clinical use, intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures (21 CFR 872.3920(a)). Unlike the plastic-tooth definition, the porcelain definition is not limited to full dentures; it names crowns and partial dentures as examples.
This page covers the two material categories that FDA’s classification database lists as separate device types. It does not cover denture base materials, adhesives or cleaning products, which are separate devices (see denture adhesive and denture cleaning tablets).
How denture teeth are used in practice
Per the two regulations above, a plastic denture tooth is used as a tooth in a denture, and a porcelain tooth is used in constructing fixed or removable prostheses. In both cases the device is a prefabricated component: it is supplied ready-made rather than created from raw material at the point of use. In FDA’s database the plastic category is titled “Denture, plastic, teeth” and the porcelain category “Teeth, porcelain”; neither is flagged as an implanted device.
Types: plastic and porcelain compared by regulation
The table below compares what FDA records for each type, which is what matters when a laboratory, clinic or supplier has to classify a product line.
| Item | Plastic denture teeth | Porcelain teeth |
|---|---|---|
| FDA product code and name | ELM, “Denture, plastic, teeth” | ELL, “Teeth, porcelain” |
| Regulation | 21 CFR 872.3590, preformed plastic denture tooth | 21 CFR 872.3920, porcelain tooth |
| Device class | Class II (special controls) | Class II |
| Premarket route | Exempt from 510(k) (subpart E of part 807), subject to the limitations in 21 CFR 872.9 | Submission type 510(k); eligible for third-party review |
| Named in the regulation as made of | Materials such as methyl methacrylate | Porcelain powder |
| Review panel | Dental | Dental |
FDA’s database lists 15 recognized consensus standards against the porcelain code, including ISO 6872 (dental ceramics), ISO 7491 (colour stability), ISO 7405 and ADA ANSI 41-2020 (biocompatibility) and ISO 9693. The plastic-tooth regulation in the Code of Federal Regulations does not itself name a standard.
Data from the FDA Product Classification database (codes ELM and ELL), the openFDA device classification API and the CFR text; full links are in the Sources section below.
Where it matters for labs, clinics and supply decisions
The practical point is that the material determines the regulation. A checklist built only from the facts above:
- Identify the material category of the tooth line: plastic (methyl methacrylate type) falls under 21 CFR 872.3590, porcelain under 21 CFR 872.3920.
- Confirm the FDA product code the manufacturer lists the line under: ELM for plastic, ELL for porcelain.
- Do not assume one premarket route. Plastic teeth are 510(k)-exempt subject to limitations; porcelain teeth carry a 510(k) submission type.
- Keep the classes apart in records. Both are Class II, but they sit in different regulations with different identification wording.
Related CASRAI pages on denture-related devices show the same approach of reading the classification before the marketing copy: denture repair kits and denture brushes.
Common misunderstandings
“All denture teeth are regulated the same way.”
They are not. FDA lists plastic and porcelain teeth under different product codes and regulations, and only the plastic type is described as exempt from 510(k) subject to limitations.
“Class II means a 510(k) is always required.”
Not necessarily. Plastic denture teeth are Class II yet exempt from 510(k) subject to the limitations in 21 CFR 872.9.
“Porcelain teeth are only for dentures.”
The regulation describes porcelain teeth as intended for fixed or removable prostheses, such as crowns and partial dentures.
FAQ
Are plastic and porcelain denture teeth regulated differently?
Yes. Plastic teeth are product code ELM under 21 CFR 872.3590, Class II and exempt from 510(k) subject to limitations. Porcelain teeth are product code ELL under 21 CFR 872.3920, Class II with a 510(k) submission type.
What material are plastic denture teeth made of?
The regulation describes them as composed of materials such as methyl methacrylate. The word “such as” means the list is illustrative, not exhaustive.
Sources
- eCFR, 21 CFR 872.3590, Preformed plastic denture tooth, ecfr.gov, checked 2026-10-30.
- eCFR, 21 CFR 872.3920, Porcelain tooth, ecfr.gov, checked 2026-10-30.
- FDA Product Classification database, code ELM, accessdata.fda.gov, checked 2026-10-30.
- FDA Product Classification database, code ELL, accessdata.fda.gov, checked 2026-10-30.
- openFDA device classification API, product codes ELL and ELM, api.fda.gov, checked 2026-10-30.
