The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent Pit And Fissure Sealant, Model 006-00019.
| Device ID | K062886 |
| 510k Number | K062886 |
| Device Name: | ASCENT PIT AND FISSURE SEALANT, MODEL 006-00019 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-26 |
| Decision Date | 2006-11-06 |
| Summary: | summary |