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Interarticular Disc Prosthesis (Interpositional Implant)

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3970 Interarticular disc prosthesis (interpositional implant)

§ 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]

Interarticular Disc Prosthesis (Interpositional Implant)

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3970
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3970 Interarticular disc prosthesis (interpositional implant)

§ 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]