The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Opal Prime & Opal Bond/orthodontic Bracket System, Models 2626, 2625, 2635, 2803, 2802.
| Device ID | K071055 |
| 510k Number | K071055 |
| Device Name: | OPAL PRIME & OPAL BOND/ORTHODONTIC BRACKET SYSTEM, MODELS 2626, 2625, 2635, 2803, 2802 |
| Classification | Bracket, Plastic, Orthodontic |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Robert Wang |
| Correspondent | Robert Wang ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | DYW |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2007-04-16 |
| Decision Date | 2007-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205107305 | K071055 | 000 |
| 00883205107299 | K071055 | 000 |