The following data is part of a premarket notification filed by Ultradent Products, Inc. with the FDA for Peak Z.
| Device ID | K131357 |
| 510k Number | K131357 |
| Device Name: | PEAK Z |
| 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 | No |
| Date Received | 2013-05-10 |
| Decision Date | 2013-09-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00883205029065 | K131357 | 000 |
| 00883205029058 | K131357 | 000 |
| 00883205023773 | K131357 | 000 |
| 00883205023766 | K131357 | 000 |