Restoration, Resin
Resin Dental Restorations are foreign dental laboratory manufactured permanent restorations made from resins as finished products, used to restore tooth structure and dental function. These devices encompass a range of tooth-colored restorative options manufactured outside the United States. The product code is NSM, 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 does not carry implant or life-sustaining support flags.
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Basic Information
- Product Code
- NSM
- Device Class
- FDA not classified
- Medical Specialty
- Unknown
- Review Panel
- DE
- Submission Type
- 7
Device Characteristics
Definition
Foreign dental lab manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
Unclassified Reason
6
FEI Numbers
This FDA classification entry is associated with 58 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 58 registration numbers. Click on an entry to view related FDA registrations.