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 |