Product Code: NSK FDA not classified

Dentures, Partial

Unknown

Partial Dentures are foreign dental laboratory manufactured prosthetic dental devices made from denture resins and other supporting materials, intended to replace some but not all teeth in a dental arch. They restore chewing function and aesthetics for patients with partial tooth loss. The product code is NSK, reviewed by the Dental panel, and carries an FDA Not Classified (N) designation with unclassified reason code 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
149
Registration Numbers
149
Unique Applicants
0
Years Active

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Basic Information

Product Code
NSK
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 partial dentures are manufactured as finished products from denture resins and other supporting materials.

Unclassified Reason

6

FEI Numbers

This FDA classification entry is associated with 149 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 149 registration numbers. Click on an entry to view related FDA registrations.