G-CEM LinkForce™ 009548

GUDID D0470095484

G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL)

Gc America Inc.

Dental cement trial
Primary Device IDD0470095484
NIH Device Record Key31fa1e5e-1773-4e5c-9829-5388bb53a1cd
Commercial Distribution Discontinuation2020-02-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameG-CEM LinkForce™
Version Model Number009548
Catalog Number009548
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
Email[email protected]

Operating and Storage Conditions

Storage Environment TemperatureBetween 4 Degrees Celsius and 25 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470095481 [Primary]
HIBCCD0470095484 [Package]
Contains: D0470095481
Package: Carton [30 Units]
Discontinued: 2020-02-05
Not in Commercial Distribution

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 Number5
Public Version Date2020-02-11
Device Publish Date2016-10-20

On-Brand Devices [G-CEM LinkForce™]

D0470095514G-CEM LinkForce™ Try-In Paste Bleach, 1 syringe (1.5g/1.2mL)
D0470095504G-CEM LinkForce™ Try-In Paste Opaque 1 syringe (1.5g/1.2mL)
D0470095494G-CEM LinkForce™ Try-In Paste Translucent 1 syringe (1.5g/1.2mL)
D0470095484G-CEM Link Force™ Try-In Paste A2, 1 syringe (1.5g/1.2mL)

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