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Joint, Temporomandibular, Implant

Page Type
Product Code
Definition
Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Physical State
The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head right in front of the ear.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3940
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3940 Total temporomandibular joint prosthesis

§ 872.3940 Total temporomandibular joint prosthesis.

(a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.

(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 total temporomandibular joint prosthesis 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 a total temporomandibular joint prosthesis that was in commercial distribution before May 28, 1976. Any other total temporomandibular joint prosthesis 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]

Joint, Temporomandibular, Implant

Page Type
Product Code
Definition
Call for PMAs to be filed by 3/30/99 per 63 FR 71746 on 12/30/98 - Indicated for reconstruction of the temporomandibular joint.
Physical State
The device is a ball and socket joint with one side mounted to the jaw and the other side mounted to the head right in front of the ear.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
PMA
Device Classification
Class 3
Regulation Number
872.3940
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.3940 Total temporomandibular joint prosthesis

§ 872.3940 Total temporomandibular joint prosthesis.

(a) Identification. A total temporomandibular joint prosthesis is a device that is intended to be implanted in the human jaw to replace the mandibular condyle and augment the glenoid fossa to functionally reconstruct the temporomandibular joint.

(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 total temporomandibular joint prosthesis 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 a total temporomandibular joint prosthesis that was in commercial distribution before May 28, 1976. Any other total temporomandibular joint prosthesis 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]