Product Code: NSP FDA not classified

Restoration, Porcelain

Unknown

Porcelain Dental Restorations are foreign dental laboratory manufactured full porcelain crown and bridge restorations made entirely from dental porcelains, offering high aesthetic qualities for tooth restoration. These finished prosthetics are produced overseas and used in restorative dentistry. The product code is NSP, 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
143
Registration Numbers
143
Unique Applicants
0
Years Active

Research product code NSP in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
NSP
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 porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.

Unclassified Reason

6

FEI Numbers

This FDA classification entry is associated with 143 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 143 registration numbers. Click on an entry to view related FDA registrations.