All Smiles Safebond 4000055911

GUDID 07899633830893

All Smiles Safebond is a single flask self-etch light-curing adhesive system (Seventh Generation) responsible for the union between tooth structure (enamel and dentin) and restorative materials.

Dentscare Ltda

Dentine bonding agent/set
Primary Device ID07899633830893
NIH Device Record Keyaca4595c-f71a-4e76-9a28-32f6887f739f
Commercial Distribution StatusIn Commercial Distribution
Brand NameAll Smiles Safebond
Version Model Number5mL
Catalog Number4000055911
Company DUNS898067533
Company NameDentscare Ltda
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 Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107899633830893 [Primary]

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-09
Device Publish Date2023-06-01

Devices Manufactured by Dentscare Ltda

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