AccessGUDID - DEVICE: G-CEM LinkForce™ (D0470095411)

GUDID

Device Identifier (DI) Information

Brand Name: G-CEM LinkForce™
Version or Model: 009541
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 009541
Company Name: Gc America Inc.

Primary DI Number: D0470095411
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: G-CEM LinkForce™ System Kit 3 LinkForce syringes (8.7g) one each of A2, Translucent Opaque, 45 regular mixing tips, 5 endo mixing tips with intraoral tip, 1 btl. G-Premio Bond 5mL, 1 btl G-Multi Primer 5mL, 1 btl G-Premio Bond DCA 3mL, 1 syringe GC Etchant 4.8g, 25 dispensing tips+2 covers (for GC Etchant & Try-in Paste), 3 syringe GC Try-in Paste (A2, Translucent, Opaque), 50 disposable applicator, 20 disposable dispensing dish

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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	CEMENT, DENTAL

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 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Store in refrigerator
Storage Environment Temperature: between 35 and 46 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: f89bca61-d177-44a3-9b74-a88440769851
Public Version Date: March 17, 2025
Public Version Number: 4
DI Record Publish Date: October 20, 2016