The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Kerr Advanced Adhesive.
Device ID | K962515 |
510k Number | K962515 |
Device Name: | KERR ADVANCED ADHESIVE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Contact | William R Pike |
Correspondent | William R Pike KERR DENTAL MATERIALS CENTER 1717 WEST COLLINS AVE. Orange, CA 92867 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1996-06-27 |
Decision Date | 1996-08-01 |
Summary: | summary |