The following data is part of a premarket notification filed by Biomers Products, Llc with the FDA for Biomers Translucent Orthodontic Bracket.
| Device ID | K101481 |
| 510k Number | K101481 |
| Device Name: | BIOMERS TRANSLUCENT ORTHODONTIC BRACKET |
| Classification | Bracket, Ceramic, Orthodontic |
| Applicant | BIOMERS PRODUCTS, LLC 18912 NORTH CREEK PARKWAY SUITE 210 Bothell, WA 98011 |
| Contact | George Aliphtiras |
| Product Code | NJM |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-05-28 |
| Decision Date | 2010-06-23 |
| Summary: | summary |