The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent Porcelain Primer, Model 006-00078, 00600079.
| Device ID | K091300 |
| 510k Number | K091300 |
| Device Name: | ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | CAO GROUP, INC. 4628 WEST SKYHAWK DRIVE West Jordan, UT 84084 |
| Contact | Robert Larson |
| Correspondent | Robert Larson 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 | 2009-05-04 |
| Decision Date | 2009-07-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00872320003272 | K091300 | 000 |
| 00872320000509 | K091300 | 000 |