The following data is part of a premarket notification filed by Gestenco International Ab with the FDA for Orthodontic Polymer Composite Bracket.
| Device ID | K053055 |
| 510k Number | K053055 |
| Device Name: | ORTHODONTIC POLYMER COMPOSITE BRACKET |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | GESTENCO INTERNATIONAL AB 14 FRIDKULLAGATAN Goteborg, SE Se 400 22 |
| Contact | Goran Steen |
| Correspondent | Goran Steen GESTENCO INTERNATIONAL AB 14 FRIDKULLAGATAN Goteborg, SE Se 400 22 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-31 |
| Decision Date | 2005-12-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07333117000216 | K053055 | 000 |
| 07333117000070 | K053055 | 000 |
| 07333117000223 | K053055 | 000 |
| 07333117000087 | K053055 | 000 |