The following data is part of a premarket notification filed by Tokuyama Dental Corporation with the FDA for Tokuyama Shield Force.
| Device ID | K100172 |
| 510k Number | K100172 |
| Device Name: | TOKUYAMA SHIELD FORCE |
| Classification | Varnish, Cavity |
| Applicant | TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Contact | Keith Barritt |
| Correspondent | Keith Barritt TOKUYAMA DENTAL CORPORATION 1425 K STREET, N.W. SUITE 1100 Washington, DC 20005 |
| Product Code | LBH |
| CFR Regulation Number | 872.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-21 |
| Decision Date | 2010-10-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190151417 | K100172 | 000 |
| 04548190151219 | K100172 | 000 |
| 04548190151110 | K100172 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() TOKUYAMA SHIELD FORCE 85348090 4343121 Live/Registered |
Tokuyama Corporation 2011-06-16 |
![]() TOKUYAMA SHIELD FORCE 77693089 not registered Dead/Abandoned |
Tokuyama Corporation 2009-03-17 |