Last synced on 16 February 2024 at 11:04 pm

Restoration, Porcelain-Fused-To-Metal

Page Type
Product Code
Definition
Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.
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 NSO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.

Restoration, Porcelain-Fused-To-Metal

Page Type
Product Code
Definition
Foreign dental lab manufactured porecelain-fused-to-metal restorations are porcelain-fused-to-metal crown and bridge restorations that are manufactured as finished products from porcelain and noble or base metal alloys.
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 NSO is assigned to devices that are "not-classified", it is not linked to any specific regulation and CFR section.