The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Opal Seal.
| Device ID | K090355 |
| 510k Number | K090355 |
| Device Name: | OPAL SEAL |
| Classification | Adhesive, Bracket And Tooth Conditioner, Resin |
| Applicant | ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Contact | Diane Rogers |
| Correspondent | Diane Rogers ULTRADENT PRODUCTS, INC. 505 WEST 10200 SOUTH South Jordan, UT 84095 |
| Product Code | DYH |
| CFR Regulation Number | 872.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-02-11 |
| Decision Date | 2009-04-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205103284 | K090355 | 000 |
| 00883205103277 | K090355 | 000 |
| 00883205103260 | K090355 | 000 |
| 00883205103253 | K090355 | 000 |
| 00883205103239 | K090355 | 000 |