The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Bond Force.
Device ID | K070215 |
510k Number | K070215 |
Device Name: | TOKUYAMA BOND FORCE |
Classification | Agent, Tooth Bonding, Resin |
Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
Contact | Robert A Silverman |
Correspondent | Robert A Silverman TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
Product Code | KLE |
CFR Regulation Number | 872.3200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-01-23 |
Decision Date | 2007-03-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04548190149926 | K070215 | 000 |
04548190149513 | K070215 | 000 |
04548190149421 | K070215 | 000 |
04548190149377 | K070215 | 000 |
04548190149322 | K070215 | 000 |
04548190149124 | K070215 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOKUYAMA BOND FORCE 77061560 3509236 Live/Registered |
TOKUYAMA CORPORATION 2006-12-11 |