{"data":{"id":"us/21-cfr-872.5525","jurisdiction":"us","citation":"21 CFR 872.5525","heading":"Preformed tooth positioner.","body":"(a) Identification. A preformed tooth positioner is a plastic device that is an impression of a perfected bite intended to prevent a patient's teeth from shifting position or to move teeth to a final position after orthodontic appliances (braces) have been removed. The patient bites down on the device for several hours a day to force the teeth into a final position or to maintain the teeth in their corrected position.\n(b) Classification. Class I (general 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.","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 F—Therapeutic 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":"79dd3e77f231b4bdccb3dfec98244dd15345dfc4cc7b0236bf10af9ada40c8ae","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-872.5500","next":"us/21-cfr-872.5550"},"notice":"GroundRules: Original legal text. Not legal advice."}