Integra Bond

GUDID 00348783000641

INTEGRA BOND 7ml

PREMIER DENTAL PRODUCTS COMPANY

Dentine bonding agent/set
Primary Device ID00348783000641
NIH Device Record Key5ebc4740-35a9-477f-a256-b5296b177164
Commercial Distribution StatusIn Commercial Distribution
Brand NameIntegra Bond
Version Model Number3001411
Company DUNS014789663
Company NamePREMIER DENTAL PRODUCTS COMPANY
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
GS100348783000641 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2023-10-17
Device Publish Date2016-09-21

On-Brand Devices [Integra Bond]

00348783000689INTEGRA BOND ADHESIVE KIT
00348783000665INTEGRA BOND 4ml
00348783000658INTEGRA AUTO CURE ACTIVATOR 7ml
00348783000641INTEGRA BOND 7ml

Trademark Results [Integra Bond]

Mark Image

Registration | Serial
Company
Trademark
Application Date
INTEGRA BOND
INTEGRA BOND
76391177 not registered Dead/Abandoned
RMO, Inc.
2002-04-03

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