Product Code: NSR FDA not classified

Prosthesis, Orthodontic

Unknown

The Orthodontic Prosthesis represents foreign dental laboratory manufactured custom-fit orthodontic prosthetic devices used in orthodontic treatment to correct dental alignment and occlusion. These finished prostheses are produced overseas for use in orthodontic practices. The product code is NSR, 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 carries no implant or life-sustaining support flags.

510(k)s
0
FEI Numbers
75
Registration Numbers
75
Unique Applicants
0
Years Active

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Basic Information

Product Code
NSR
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 orthodontic prosthesis are finished custom-fit orthodontic prosthesis.

Unclassified Reason

6

FEI Numbers

This FDA classification entry is associated with 75 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 75 registration numbers. Click on an entry to view related FDA registrations.