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Title 21 → Chapter I → Subchapter H → Part 872 → Subpart D → §872.3630 |
Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices
§872.3630 Endosseous dental implant abutment.
(a) Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.
(b) Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See §872.1(e) for the availability of this guidance document.)
[69 FR 26304, May 12, 2004]