The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Peak Bond, Model 5133.
| Device ID | K063557 |
| 510k Number | K063557 |
| Device Name: | PEAK BOND, MODEL 5133 |
| Classification | Agent, Tooth Bonding, 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 | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-27 |
| Decision Date | 2006-12-12 |
| Summary: | summary |