Product Code: NSM FDA not classified

Restoration, Resin

Unknown

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.

510(k)s
0
FEI Numbers
58
Registration Numbers
58
Unique Applicants
0
Years Active

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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

GMP Exempt
Implant
Life Sustain/Support
Third Party
Summary Malfunction Reporting

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.