EBO · Denture Repair Kit
Dental · 21 CFR 872.3570 · Class 2
Overview
| Product Code | EBO |
|---|---|
| Device Name | Denture Repair Kit |
| Regulation | 21 CFR 872.3570 |
| Device Class | Class 2 |
| Review Panel | Dental |
Identification
An OTC denture repair kit is 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. The device may be available for purchase over-the counter.
Classification Rationale
Class II. The OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 872.9. The special controls for this device are FDA's:
Special Controls
*Classification.* Class II. The OTC denture repair kit is exempt from premarket notification procedures in subpart E of part 807 of this chapter, subject to § 872.9. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and (2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”
Recent Cleared Devices (7 of 7)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850927 | COMPLETE DENTURE REPAIR KIT | Tooth Aid Lab, Inc. | Jul 2, 1985 | SESE |
| K844480 | DENTAL ORAL CARE SYSTEMS & COMPONENTS | Advanced Bio Systems, Inc. | Jun 19, 1985 | SN |
| K833057 | UNIVERSAL FIX-A-PLATE | Laurentian Laboratories | Feb 27, 1984 | SESE |
| K833056 | UNIVERSAL LINE-A-PLATE | Laurentian Laboratories | Feb 27, 1984 | SESE |
| K820685 | DENTURE ADJUSTMENT KIT | Camdent Laboratories | Apr 9, 1982 | SESE |
| K820245 | SAFE TDENT | Professional Dental Studios | Apr 9, 1982 | SESE |
| K770091 | EMERGENCY FAST-FIX DENTURE REPAIR KIT | Mr. Clarence Hurst | Jan 24, 1977 | SESE |
Top Applicants
- Laurentian Laboratories — 2 clearances
- Tooth Aid Lab, Inc. — 1 clearance
- Professional Dental Studios — 1 clearance
- Mr. Clarence Hurst — 1 clearance
- Camdent Laboratories — 1 clearance
