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 |