One-UP Bond F Plus

GUDID 04548190147366

Bonding Agent A

TOKUYAMA DENTAL CORPORATION

Dentine adhesive
Primary Device ID04548190147366
NIH Device Record Keyaeefa9bb-0665-4ee9-96f1-e846bcf17105
Commercial Distribution StatusIn Commercial Distribution
Brand NameOne-UP Bond F Plus
Version Model Number14736
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 Kitfalse
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
GS104548190147366 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2016-09-23

On-Brand Devices [One-UP Bond F Plus ]

04548190147373Bonding Agent B
04548190147366Bonding Agent A
04548190147069Kit

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