Last synced on 23 September 2022 at 11:05 pm

Prosthesis, Orthodontic

Page Type
Product Code
Definition
Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Review Panel
Dental
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code NSR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Prosthesis, Orthodontic

Page Type
Product Code
Definition
Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Review Panel
Dental
Submission Type
Enforcement Discretion
Device Classification
N
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

No Linked CFR Text

As product code NSR is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.