Written and maintained by CASRAI Editorial Board
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General product and regulatory information only, not medical or dental advice.
Purpose and setting: what a denture repair kit is
A denture repair kit is an over-the-counter device for mending a cracked or broken denture, and in the United States it is regulated by the FDA as a Class II device under product code EBO. The regulation, 21 CFR 872.3570, describes it as “a device consisting of a material, such as a resin monomer system of powder and liquid glues, that is intended to be applied permanently to a denture to mend cracks or breaks,” and says it “may be available for purchase over-the-counter.”
This page is for people comparing what a kit is, what its label has to say, and how it differs from related products such as reliners and adhesives. It does not give repair steps; follow the directions printed on the product you hold.
What the regulation and FDA guidance say a kit consists of and must disclose
The rules do not publish a fixed parts list. They define the kit by its material (a resin monomer system, such as a powder and a liquid) and set out what the labeling and formulation information must contain. The table below lists only items stated in the two FDA sources. Contents beyond these vary by product and are set by the manufacturer.
| Item | Typical or required | Why it matters | Source note |
|---|---|---|---|
| Resin monomer system, such as powder and liquid | Typical, per the regulation’s wording (“such as”) | This is the repair material that is applied to the denture | 21 CFR 872.3570(a) |
| Directions for use | Required: labeling must bear “adequate directions for use” | The directions, not a general guide, govern how a specific kit is used | FDA guidance, labeling section |
| Warning statement | Warning wording recommended in the FDA guidance (quoted below) | Signals the kit is for emergency repairs, not long-term use | FDA guidance |
| Formulation by component | Components identified by percentage in the premarket information | Lets a reviewer see what the resin system contains | FDA guidance |
| Single-paste or two-paste statement | The submission must “clearly specify whether a single paste or two paste (base/catalyst) system is employed” | Shows which kind of system the kit uses | FDA guidance |
The recommended emergency-use warning
The FDA guidance, citing 21 CFR 801.405, lists this recommended warning wording for denture repair kits: “Warning—For emergency repairs only. Long term use of home-repaired dentures may cause faster bone loss, continuing irritation, sores, and tumors. This kit for emergency use only. See Dentist Without Delay.”
The wording is the clearest statement of how the FDA frames the product: an interim, emergency measure, not a replacement for professional care. The guidance lists a separate recommended warning for reliners, pads and cushions.
What varies by kit type
Repair kit versus reliner
FDA treats repair kits and reliners as separate products under the same guidance, with different warnings and different consensus-standard references. For repair kits the guidance lists the ADA standard for denture cold-curing repair resins (#13); for reliners it lists temporary relining resins (#17). A repair kit mends a crack or break; a reliner is a different product category. Adhesives and cleaning products are also separate categories; see denture adhesive, denture cleaning tablets, denture brush and manual toothbrush.
Single-paste versus two-paste systems
The guidance asks manufacturers to state whether the system is a single paste or a two-paste base and catalyst arrangement, and to list all components of the system or kit. Which type a given product is must be read from its own label.
Which FDA rules apply
- Classification: Class II, product code EBO, under 21 CFR 872.3570 (eCFR text checked 2026-10-30).
- Premarket notification: the regulation exempts the device from 510(k) procedures, subject to 21 CFR 872.9. The FDA guidance page states: “As of January 31, 2018, over-the-counter denture repair kits (Product Code EBO, 21 CFR 872.3570) are exempt from premarket notification (510(k)).”
- Special controls: FDA’s document on use of ISO 10993 (biological evaluation of medical devices) and its guidance “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
- Consensus standard: the guidance lists ADA #13 for cold-curing repair resins; see the CASRAI entry on FDA-recognized consensus standards for how FDA uses such standards in general.
FAQ
Is a denture repair kit a medical device?
Yes. 21 CFR 872.3570 classifies the OTC denture repair kit as a Class II device.
Does a denture repair kit need 510(k) clearance?
No. Since January 31, 2018 FDA lists over-the-counter denture repair kits (product code EBO) as exempt from premarket notification, subject to the general limitations in 21 CFR 872.9.
Is a kit repair meant to be permanent?
The regulation describes the material as applied “permanently” to mend cracks or breaks, but the required warning says the kit is “for emergency repairs only” and refers the user to a dentist.
Sources
- eCFR, 21 CFR 872.3570, OTC denture repair kit: https://www.ecfr.gov/current/title-21/part-872/section-872.3570. Checked 2026-10-30.
- FDA, “OTC Denture Cushions, Pads, Reliners, Repair Kits, and Partially Fabricated Denture Kits – Guidance for Industry and FDA Staff” (issued August 18, 1998): https://www.fda.gov/regulatory-information/search-fda-guidance-documents/otc-denture-cushions-pads-reliners-repair-kits-and-partially-fabricated-denture-kits-guidance. Checked 2026-10-30.
