Prosthesis, Orthodontic
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.
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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
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.