Last synced on 30 September 2022 at 11:05 pm

Restoration, Porcelain

Page Type
Product Code
Definition
Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
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 NSP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Restoration, Porcelain

Page Type
Product Code
Definition
Foreign dental lab manufactured porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
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 NSP is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.