{"data":{"id":"us/21-cfr-872.3330","jurisdiction":"us","citation":"21 CFR 872.3330","heading":"Preformed crown.","body":"(a) Identification. A preformed crown is a prefabricated device made of plastic or austenitic alloys or alloys containing 75 percent or greater gold and metals of the platinum group intended to be affixed temporarily to a tooth after removal of, or breakage of, the natural crown (that portion of the tooth that normally protrudes above the gums). It is intended for use as a functional restoration until a permanent crown is constructed. The device also may be intended for use as a functional restoration for a badly decayed deciduous (baby) tooth until the adult tooth erupts.\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 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":"4262672c32847767c37ba2db7f2a022ef5f3e36de21e85f5e3ff9a319893cf3e","source_id":"us-cfr","stale":true,"prev":"us/21-cfr-872.3310","next":"us/21-cfr-872.3350"},"notice":"GroundRules: Original legal text. Not legal advice."}