The following data is part of a premarket notification filed by Biomers Product, Llc with the FDA for Biomers Translucent Orthodontic Wire.
| Device ID | K081143 |
| 510k Number | K081143 |
| Device Name: | BIOMERS TRANSLUCENT ORTHODONTIC WIRE |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | BIOMERS PRODUCT, LLC 2316 PINE RIDGE ROAD SUITE 459 Naples, FL 34109 |
| Contact | George Aliphtiras |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2008-04-22 |
| Decision Date | 2008-05-02 |
| Summary: | summary |