AccessGUDID - DEVICE: Coating Material (04560227798990)

GUDID

Device Identifier (DI) Information

Brand Name: Coating Material
Version or Model: MC-002
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: KS51US
Company Name: SUN MEDICAL CO.,LTD.

Primary DI Number: 04560227798990
Issuing Agency: GS1
Commercial Distribution End Date: July 27, 2017
Device Count: 1
Labeler D-U-N-S® Number*: 690922612 *Terms of Use

Device Description: Coating Material is a light-cured denture base coating that is composed of two liquids that are mixed prior to use, and then photo-polymerized by a UV light. The coated surface provides smoothness and glossiness to the surface of an acrylic denture base. The coated layer is transparent, so it does not affect the original color of the denture.

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):	No
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?
17609	Denture reliner, hard	A denture relining material intended to be applied by a dentist or dental laboratory technician as a permanent coating or lining on the base or tissue-contact surface of a denture and which sets to a hard state. Denture relining is defined as a process of providing a new fitting surface to a denture. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBI	Resin, Denture, Relining, Repairing, Rebasing

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 1 and 10 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
Weight: 1.43 Kilogram

Device Record Status

Public Device Record Key: 43d5fa2e-f263-45f9-82f3-daa4698f823e
Public Version Date: August 09, 2018
Public Version Number: 3
DI Record Publish Date: November 09, 2016