{"data":{"id":"us/21-cfr-872.3560","jurisdiction":"us","citation":"21 CFR 872.3560","heading":"OTC denture reliner.","body":"(a) Identification. An OTC denture reliner is a device consisting of a material such as plastic resin that is intended to be applied as a permanent coating or lining on the base or tissue-contacting surface of a denture. The device is intended to replace a worn denture lining and may be available for purchase over the counter.\n(b) Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 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":"918269c0affb15bf455547536fcdbcafee6a4c86b933867b237e3dee65a948a4","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-872.3540","next":"us/21-cfr-872.3570"},"notice":"GroundRules: Original legal text. Not legal advice."}