Product Code: NSN FDA not classified

Restoration, Resin, Crown And Bridge

Unknown

Resin Crown and Bridge Restorations are foreign dental laboratory manufactured crown and bridge prostheses made entirely from resin materials, used to restore individual teeth or spans of missing teeth. These finished restorations are produced in overseas dental laboratories for use in dental practices. The product code is NSN, 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
109
Registration Numbers
109
Unique Applicants
0
Years Active

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Basic Information

Product Code
NSN
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 crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.

Unclassified Reason

6

FEI Numbers

This FDA classification entry is associated with 109 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 109 registration numbers. Click on an entry to view related FDA registrations.