Last synced on 1 March 2024 at 11:05 pm

Restoration, Resin

Page Type
Product Code
Definition
Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
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 NSM is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Restoration, Resin

Page Type
Product Code
Definition
Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
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 NSM is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.