{"data":{"id":"us/21-cfr-872.3570","jurisdiction":"us","citation":"21 CFR 872.3570","heading":"OTC denture repair kit.","body":"(a) 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.\n(b) 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:\n(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” and\n(2) “OTC Denture Reliners, Repair Kits, and Partially Fabricated Denture Kits.”","path":["Title 21—Food and Drugs","CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES","SUBCHAPTER H—MEDICAL DEVICES","PART 872—DENTAL DEVICES","Subpart D—Prosthetic Devices"],"source_url":"https://www.ecfr.gov/api/versioner/v1/full/2026-08-25/title-21.xml","current_through":"2026-08-25","vintage":"","retrieved_at":"2026-08-27T02:24:47Z","sha256":"4f5bb9d2c8cfa8f0f9b36f4905be93e7ed0c5a3f25dee1aadf212121925f2e39","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-872.3560","next":"us/21-cfr-872.3580"},"notice":"GroundRules: Original legal text. Not legal advice."}