G-CEM LinkForce™ 009551

GUDID D0470095514

G-CEM LinkForce™ Try-In Paste Bleach, 1 syringe (1.5g/1.2mL)

Gc America Inc.

Dental cement trial
Primary Device IDD0470095514
NIH Device Record Key9e02952b-7e70-4e44-8c6c-6b7727a4445f
Commercial Distribution Discontinuation2020-02-05
Commercial Distribution StatusNot in Commercial Distribution
Brand NameG-CEM LinkForce™
Version Model Number009551
Catalog Number009551
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 39 Degrees Fahrenheit and 77 Degrees Fahrenheit

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD0470095511 [Primary]
HIBCCD0470095514 [Package]
Contains: D0470095511
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)

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.