NSRNot classified

Prosthesis, Orthodontic

Unknown

NSR is the FDA product code for Prosthesis, Orthodontic. FDA's definition for this code reads: "Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis". As of 2026-09-10, FDA records hold no 510(k) clearances under this code and one recall.

Classification record

Product code: NSR
Device name: Prosthesis, Orthodontic
FDA definition: Foreign dental lab manufactured orthodontic prosthesis are finished custom-fit orthodontic prosthesis.
Device class: Not classified
Review panel: Unknown
Submission type: FDA code 7
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 0
Ingested recalls: 1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 72 companies shown, in name order

Recent clearances

Product code NSR

FDA records hold no clearances under product code NSR.

Recent recalls

Product code NSR

Z-1378-05A problem in the software has the potential to be associated with the incorrect reporting of sample results.Cepheid / initiated 2005-07-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device classification database, ingested from openFDA. The definition, regulation number, device class and review panel are FDA’s own fields, reproduced without editing.

MDM adds the counts: clearances by decision year, the applicants holding the most clearances under this code, recalls that name it, and the registered establishments that list it. Every count is computed from ingested records only.

Data as of 2026-10-05, the FDA export date for this dataset. Page last changed 2026-09-05. View this product code on fda.gov (opens on fda.gov)