The following data is part of a premarket notification filed by Biomers Products, Llc with the FDA for Simpliclear Rectangular Orthodontic Wire.
| Device ID | K110796 |
| 510k Number | K110796 |
| Device Name: | SIMPLICLEAR RECTANGULAR ORTHODONTIC WIRE |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | BIOMERS PRODUCTS, LLC 1275 WEST 6TH AVENUE SUITE 399 Vancouver, Bc, CA V6h 1a6 |
| Contact | Daryl Wisdahl |
| Correspondent | William Sammons 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 | 2011-03-22 |
| Decision Date | 2011-03-31 |
| Summary: | summary |