Tokuyama Shield Force Plus

GUDID 04548190151110

Kit

TOKUYAMA DENTAL CORPORATION

Dental cavity varnish
Primary Device ID04548190151110
NIH Device Record Key33424d6d-097c-435b-814a-0d5141b42bca
Commercial Distribution StatusIn Commercial Distribution
Brand NameTokuyama Shield Force Plus
Version Model Number15111
Company DUNS693552176
Company NameTOKUYAMA DENTAL CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-877-378-3548
Emailinfo@tokuyama-us.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 0 Degrees Celsius and 10 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS104548190151110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LBHVarnish, Cavity

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-02-07
Device Publish Date2016-09-23

On-Brand Devices [Tokuyama Shield Force Plus]

04548190151417Mini-kit
04548190151219Refill
04548190151110Kit

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.