Bonding Agent (Self-Cure) Part A & Part B 1018

GUDID D83610181

• Simple and fast application technique. • Compatible with all light-cured, and self-cured restorative materials and cements. • Long shelf-life with no need for refrigeration. • Economical. • No pulp irritation.

DENT ZAR, INC.

Dentine bonding agent/set
Primary Device IDD83610181
NIH Device Record Keyd4ac9435-27bf-4f64-9c91-a8acc9a57042
Commercial Distribution StatusIn Commercial Distribution
Brand NameBonding Agent (Self-Cure) Part A & Part B
Version Model Number1018
Catalog Number1018
Company DUNS789664455
Company NameDENT ZAR, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD83610181 [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 Date2016-09-03

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