Restoration, Porcelain-Fused-To-Metal
Porcelain-Fused-to-Metal Dental Restorations are foreign dental laboratory manufactured crown and bridge restorations combining porcelain aesthetics with the strength of noble or base metal alloy substructures. These finished prosthetic devices are used to restore damaged or missing teeth. The product code is NSO, reviewed by the Dental panel, and carries an FDA Not Classified (N) designation with unclassified reason code 6 for foreign manufacturing. No regulation number is assigned, and the device carries no implant or life-sustaining support flags.
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Basic Information
- Product Code
- NSO
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
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.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 141 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 141 registration numbers. Click on an entry to view related FDA registrations.