AccessGUDID - DEVICE: GC Initial™ (EKLE8781171)

GUDID

Device Identifier (DI) Information

Brand Name: GC Initial™
Version or Model: 878117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 878117
Company Name: Gc America Inc.

Primary DI Number: EKLE8781171
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005473608 *Terms of Use

Device Description: GC Initial™ Zirconia Disk Standard Translucency (ST) - 25mm Dimensions: 98.5mm x 25mm.

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?
16187	Dental appliance fabrication material, ceramic	A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K082740	000

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
Weight: 570 Gram

Device Record Status

Public Device Record Key: b6bf7e30-c822-45f9-bcbf-53a2473dc96e
Public Version Date: July 24, 2018
Public Version Number: 4
DI Record Publish Date: August 01, 2016