DENTAL ORAL CARE SYSTEMS & COMPONENTS
Device Facts
| Record ID | K844480 |
|---|---|
| Device Name | DENTAL ORAL CARE SYSTEMS & COMPONENTS |
| Applicant | Advanced Bio Systems, Inc. |
| Product Code | EBO · Dental |
| Decision Date | Jun 19, 1985 |
| Decision | SN |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.3570 |
| Device Class | Class 2 |
Regulatory Classification
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.
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.”
