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e-CFR data is current as of March 2, 2021

Title 21Chapter ISubchapter HPart 872Subpart D → §872.3970


Title 21: Food and Drugs
PART 872—DENTAL DEVICES
Subpart D—Prosthetic Devices


§872.3970   Interarticular disc prosthesis (interpositional implant).

(a) Identification. An interarticular disc prosthesis (interpositional implant) is a device that is intended to be an interface between the natural articulating surface of the mandibular condyle and glenoid fossa.

(b) Classification. Class III.

(c) Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before March 30, 1999, for any interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976, or that has on or before March 30, 1999, been found to be substantially equivalent to an interarticular disc prosthesis (interpositional implant) that was in commercial distribution before May 28, 1976. Any other interarticular disc prosthesis (interpositional implant) shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.

[59 FR 65478, Dec. 20, 1994, as amended at 63 FR 71746, Dec. 30, 1998]

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