The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent Bond Universal Adhesive System, Models 006-00029, 006-00030, 006-00044, 006-00045.
| Device ID | K092616 |
| 510k Number | K092616 |
| Device Name: | ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Contact | Robert K Larsen |
| Correspondent | Robert K Larsen CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2009-10-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00872320000141 | K092616 | 000 |
| 00872320000127 | K092616 | 000 |