# K101481: Biomers Translucent Orthodontic Bracket

- Pathway: 510(k) (Traditional)
- Applicant: Biomers Products, LLC
- Decided: Jun 23, 2010 after 26 days
- Product code: NJM (Bracket, Ceramic, Orthodontic)
- Device class: 2
- Regulation: 21 CFR 872.5470
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K073045 (2007). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090567: Orthodontic Ceramic Bracket, Star Dentech Korea., Corp (2009) Summary page 1.
- K073045: Sapphire Ceramic Bracket, Ortho Technology, Inc. (2007) Summary page 1.

## Indications for use
The Translucent Orthodontic Bracket is indicated for orthodontic movement of natural teeth, excluding mandibular bicuspid teeth.

Source page: https://510kreport.com/device/K101481
Methodology: https://510kreport.com/methodology