AccessGUDID - DEVICE: G-CEM LinkForce™ (D0470095491)

GUDID

Device Identifier (DI) Information

Brand Name: G-CEM LinkForce™
Version or Model: 009549
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 009549
Company Name: Gc America Inc.

Primary DI Number: D0470095491
Issuing Agency: HIBCC
Commercial Distribution End Date: February 05, 2020
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: G-CEM LinkForce™ Try-In Paste Translucent 1 syringe (1.5g/1.2mL)

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61482	Dental cement trial	A non-sterile substance intended to be used as a guide for selecting a good aesthetic match to the final dental cement to be used in a dental restoration of appliance procedure. It is typically supplied as a water-soluble paste consisting of glycerin, mineral fillers and pigments that does not cure and is intended to be washed off from the restoration and preparation surface prior to final cementation. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	MATERIAL, TOOTH SHADE, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 25 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 83d45e44-24b1-402f-b7cf-8c9fe96fe19b
Public Version Date: March 17, 2025
Public Version Number: 6
DI Record Publish Date: October 20, 2016