The following data is part of a premarket notification filed by Kerr Dental Materials Center with the FDA for Temp Bond Clear.
Device ID | K972844 |
510k Number | K972844 |
Device Name: | TEMP BOND CLEAR |
Classification | Cement, Dental |
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 | EMA |
CFR Regulation Number | 872.3275 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-01 |
Decision Date | 1997-10-03 |
Summary: | summary |