21 CFR 872.3570 — Denture Repair Kit
Dental (DE) · Subpart D—Prosthetic Devices · § 872.3570
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:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| EBO | Denture Repair Kit | 2 | 7 |
Special Controls
EBO — Denture Repair Kit
*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.”
eCFR
EBO — Denture Repair Kit
(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.”
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