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 |