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General product and regulatory information only; this is not dental or medical advice.
Short answer
A denture reliner is a material, such as a plastic resin, applied as a coating or lining on the tissue-contacting surface of a denture to replace a worn lining. In the United States, the over-the-counter version is a Class II device under 21 CFR 872.3560 (FDA product code EBP) that is exempt from 510(k) premarket notification, and FDA’s guidance recommends a “for temporary use only” warning on its label.
Definition and scope
21 CFR 872.3560 defines an OTC denture reliner as “a device consisting of a material such as plastic resin” that is “intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture.” The same paragraph says the device is intended to replace a worn denture lining and may be available for purchase over the counter (text as published in the eCFR, checked 2026-10-30).
The wording matters for supply and compliance work because “reliner” is used for more than one regulated product. FDA’s product classification database lists two different product codes that mention relining, and they sit under different regulations (see the table below). This page covers the over-the-counter category; it does not describe how a reline is carried out.
How FDA regulates relining materials
FDA’s classification records and the CFR text give two distinct entries. The comparison below uses only those records.
| Item | OTC denture reliner | Relining, repairing, rebasing resin |
|---|---|---|
| FDA product code | EBP, “Reliner, Denture, Over The Counter” | EBI, “Resin, Denture, Relining, Repairing, Rebasing” |
| Regulation number | 21 CFR 872.3560 | 21 CFR 872.3760 |
| Device class | Class II (special controls) | Class II |
| Premarket notification | Exempt from 510(k), subject to the limitations in 21 CFR 872.9 | Recorded as a 510(k) submission type |
The table reflects the openFDA device classification API and the FDA product classification database, checked 2026-10-30. A common mistake is attributing product code EBI to 872.3560; the two codes sit under different regulation numbers.
For the OTC reliner, 21 CFR 872.3560(b) names two special controls: FDA’s “Use of International Standard ISO 10993, Biological Evaluation of Medical Devices, Part I: Evaluation and Testing,” and FDA’s guidance “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.” For background on how consensus standards are used in device regulation, see FDA recognized consensus standards, and for the statute behind device classes see the Medical Device Amendments of 1976.
The label warning and the word “permanent”
Two source statements sit side by side, and both are accurate as quoted. The regulation describes a reliner as applied “as a permanent coating or lining.” FDA’s guidance, however, recommends this warning for denture reliners, pads and cushions, citing 21 CFR 801.405: “For temporary use only. Long term use of this product may lead to faster bone loss, continuing irritation, sores, and tumors. For Use Only Until A Dentist Can Be Seen.”
The regulation’s “permanent” describes how the material is applied to the denture base. The warning describes how FDA recommends the product be labeled for consumer use. The guidance, dated August 18, 1998, also says labeling must bear clear, accurate and complete information on indications, preparation, hazards, contraindications and precautions, and that advertising accompanying the device can be considered labeling.
Reliner, repair kit and adhesive are different products
- Reliner: a lining material intended to replace a worn lining (21 CFR 872.3560).
- Repair kit: per FDA’s guidance, a resin monomer system of powder and liquid adhesives applied to repair cracks or breaks (21 CFR 872.3570). Its recommended warning reads “For emergency repairs only.” See denture repair kits.
- Adhesive: covered on its own page, denture adhesive; it is not a lining material.
Cleaning and care products form a further group; see denture brushes.
What FDA’s guidance covers for a reliner submission
For anyone reading a manufacturer’s documentation, FDA’s guidance gives a concrete reference list. Each item below comes from the guidance text.
| Topic | What the guidance says |
|---|---|
| Recognized standard | Lists the ANSI/ADA specification “Denture Base Temporary Relining Resins,” No. 17, alongside No. 12 (denture base polymers) and No. 13 (denture cold-curing repair resins). |
| Bench testing | A summary of the methodology and results of all bench testing should be provided. |
| Biocompatibility | Indicated when the product contains a “new” or nonconventional chemical component; testing is on the finished product. Minimum tests listed: in vitro cytotoxicity, Ames test for mutagenicity, mucus membrane irritation (hamster pouch), sensitization in guinea pigs, and carcinogenicity if tumorigenic potential has not been documented. |
| Labeling | Package labels and labeling, including promotion and advertising, are included in the 510(k) submission; recommended warning quoted above. |
This table describes what FDA’s guidance asks of manufacturers. It is not a purchasing rule, and the guidance itself is from 1998 (FDA’s page was last reviewed 2018-03-14).
Common misunderstandings
- “A reliner is a repair kit.” They are listed under different regulations (872.3560 and 872.3570) with different recommended warnings.
- “510(k)-exempt means unregulated.” The exemption applies to premarket notification, subject to 21 CFR 872.9; the device is still Class II with the two special controls above.
- “All product code EBI items are OTC.” The EBP code is the over-the-counter reliner; EBI is a separate resin code under a different regulation.
- “The regulation and the warning conflict.” They address different things: how the material is applied, and the consumer-labeling warning FDA recommends.
Frequently asked questions
What is a denture reliner?
Under 21 CFR 872.3560, it is a device consisting of a material such as plastic resin, intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture, and intended to replace a worn denture lining.
How does FDA classify an over-the-counter denture reliner?
As a Class II device (special controls) under product code EBP, exempt from premarket notification subject to the limitations in 21 CFR 872.9.
What is the difference between product codes EBP and EBI?
EBP is the over-the-counter reliner under 21 CFR 872.3560. EBI is “Resin, Denture, Relining, Repairing, Rebasing” under 21 CFR 872.3760, listed with a 510(k) submission type.
What warning does FDA recommend on a reliner label?
FDA’s 1998 guidance gives the wording quoted in the label warning section above, beginning “For temporary use only.”
Is a reliner the same as a repair kit or adhesive?
No. A repair kit falls under 21 CFR 872.3570 with its own recommended warning, and adhesive is a separate product covered on its own page.
Sources
- 21 CFR 872.3560, OTC denture reliner, via Cornell LII, law.cornell.edu/cfr/text/21/872.3560, checked 2026-10-30.
- FDA, “OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits – Guidance for Industry and FDA Staff,” August 18, 1998, fda.gov/media/72467/download, checked 2026-10-30.
- FDA Product Classification, codes EBP and EBI, accessdata.fda.gov, EBP and EBI; openFDA device classification API, api.fda.gov/device/classification.json, checked 2026-10-30.
