GC COMPOSITE PRIMER 001530

GUDID 14548161391955

GC COMPOSITE PRIMER 3 mL liquid

Gc America Inc.

Dental etching solution
Primary Device ID14548161391955
NIH Device Record Keyb67537c9-3d02-4de2-b928-29d275d4974d
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC COMPOSITE PRIMER
Version Model Number001530
Catalog Number001530
Company DUNS005473608
Company NameGc America Inc.
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

Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com
Phone+1(708)597-0900
Emailcustomerservice@gcamerica.com

Device Dimensions

Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter
Total Volume3 Milliliter

Device Identifiers

Device Issuing AgencyDevice ID
GS114548161391955 [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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-15
Device Publish Date2022-08-05

Devices Manufactured by Gc America Inc.

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D0470101234 - G-CEM LinkForce™2025-03-17 G-CEM LinkForce™ Cement Refill Bleach, 1 syringe (8.7g/5mL) 20 regular mixing tips

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