GC KommonBaseTM 90-1300-0000

GUDID E53590130000001

GC KommonBaseTM LV Pink 2 syringe pack

Gc Orthodontics America Inc.

Light-cured dental restorative composite resin
Primary Device IDE53590130000001
NIH Device Record Keyf8153392-fc10-450b-a898-d0e93756ee73
Commercial Distribution StatusIn Commercial Distribution
Brand NameGC KommonBaseTM
Version Model Number90-1300-0000
Catalog Number90-1300-0000
Company DUNS063167128
Company NameGc Orthodontics 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)897-8859
EmailGCOAInfo@gcorthodontics.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE53590130000001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DYHADHESIVE, BRACKET AND TOOTH CONDITIONER, 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 Date2016-08-01

On-Brand Devices [GC KommonBaseTM]

E53590130000001GC KommonBaseTM LV Pink 2 syringe pack
E53590120000001GC KommonBaseTM HV Clear 2 syringe pack

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