Product Code: NSJ FDA not classified

Restoration, Noble Metal

Unknown

Noble Metal Dental Restorations are foreign dental laboratory manufactured crowns, bridges, inlays, and onlays made from noble metals as finished products. These devices are intended for dental restoration to replace missing tooth structure and restore dental function and aesthetics. The product code is NSJ, reviewed by the Dental panel, and carries an FDA Not Classified (N) designation, with an unclassified reason code of 6 indicating 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
104
Registration Numbers
104
Unique Applicants
0
Years Active

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Basic Information

Product Code
NSJ
Device Class
FDA not classified
Medical Specialty
Unknown
Review Panel
DE
Submission Type
3

Device Characteristics

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

Definition

Foreign dental lab manufactured noble metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from noble metals.

FEI Numbers

This FDA classification entry is associated with 104 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 104 registration numbers. Click on an entry to view related FDA registrations.