The following data is part of a premarket notification filed by Cao Group, Inc. with the FDA for Ascent Universal Adhesive, Model 006-00028.
Device ID | K070413 |
510k Number | K070413 |
Device Name: | ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 |
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 | 2007-02-12 |
Decision Date | 2007-04-26 |
Summary: | summary |