Prosthetic devices · 21 CFR 872 Subpart D

Denture Repair Kit

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

FDA codeEBOClass221 CFR872.3570PathwayEnforcement discretion

Companies listing it: 64 makers
Brands and models: 4
510(k) clearances: 70 in five years
FDA name: Denture Repair Kit

510(k) clearances per year, 1976–2026

Companies that list EBO

6 companies currently list this device type with FDA.

Company	Country	Role	Brands and models listed	Clearances	Latest
George Taub Products & Fusion Co., Inc.	United States	Maker	Fusion Kit	2	1986
DOC BRANDS, Inc.	United States	Maker	Repair-It	—	—
Kashmir Surgical Works	India	Maker	Denture Repair Kit	—	—
Cardinal Health 200, LLC	United States	Maker	—	—	—
Perma Laboratories	United States	Manufacturer	P.E.R.K.	1	2012
STERIS Corporation	United States	Contract sterilizer	—	—	—

510(k) clearances

Decided	510(k)	Device	Applicant
2 Jul 1985	K850927	COMPLETE DENTURE REPAIR KIT	Tooth Aid Lab, Inc.
19 Jun 1985	K844480	DENTAL ORAL CARE SYSTEMS & COMPONENTS	Advanced Bio Systems, Inc.
27 Feb 1984	K833057	UNIVERSAL FIX-A-PLATE	Laurentian Laboratories
27 Feb 1984	K833056	UNIVERSAL LINE-A-PLATE	Laurentian Laboratories
9 Apr 1982	K820685	DENTURE ADJUSTMENT KIT	Camdent Laboratories
9 Apr 1982	K820245	SAFE TDENT	Professional Dental Studios
24 Jan 1977	K770091	EMERGENCY FAST-FIX DENTURE REPAIR KIT	Mr. Clarence Hurst

Official records: FDA product classification for EBO · 21 CFR 872.3570.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026