Last synced on 2 December 2022 at 11:04 pm

Material, Impression

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3660 Impression material

§ 872.3660 Impression material.

(a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

(b) Classification. Class II (Special Controls).

[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]

Material, Impression

Page Type
Product Code
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3660
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3660 Impression material

§ 872.3660 Impression material.

(a) Identification. Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient's teeth and gums. The device is intended to provide models for study and for production of restorative prosthetic devices, such as gold inlays and dentures.

(b) Classification. Class II (Special Controls).

[52 FR 30097, Aug. 12, 1987, as amended at 68 FR 19738, Apr. 22, 2003]