Last synced on 27 January 2023 at 11:04 pm

Crown And Bridge, Long-Term Temporary, Resin

Page Type
Product Code
Definition
For the fabrication of long-term temporary crowns and bridges
Physical State
Polymeric, may include ceramic filler
Technical Method
Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication
Target Area
oral cavity
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3770 Temporary crown and bridge resin

§ 872.3770 Temporary crown and bridge resin.

(a) Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

(b) Classification. Class II.

Crown And Bridge, Long-Term Temporary, Resin

Page Type
Product Code
Definition
For the fabrication of long-term temporary crowns and bridges
Physical State
Polymeric, may include ceramic filler
Technical Method
Achieves its intended function by providing a patient-matched crown or bridge that is cemented onto a patient's dentition to restore normal mastication
Target Area
oral cavity
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.3770
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Third Party Eligible

CFR § 872.3770 Temporary crown and bridge resin

§ 872.3770 Temporary crown and bridge resin.

(a) Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

(b) Classification. Class II.