Product Code: NSQ FDA not classified

Restoration, Base Metal

Unknown

Base Metal Dental Restorations are foreign dental laboratory manufactured crowns, bridges, inlays, and onlays made from base metal alloys as finished products. These prosthetic restorations are used to repair and replace tooth structure, providing durable function in the oral environment. The product code is NSQ, 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
NSQ
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 base metal restorations are crowns, bridges, inlays, and onlays that are manufactured as finished products from base metals.

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.