The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Peak Universal Bond (light Cure Resin Adhesive And Chlorhexidine).
| Device ID | K100752 |
| 510k Number | K100752 |
| Device Name: | PEAK UNIVERSAL BOND (LIGHT CURE RESIN ADHESIVE AND CHLORHEXIDINE) |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2010-03-17 |
| Decision Date | 2010-07-16 |
| Summary: | summary |