AccessGUDID - DEVICE: Porcelain Repair Kit (Green) (D7796610053)

GUDID

Device Identifier (DI) Information

Brand Name: Porcelain Repair Kit (Green)
Version or Model: 661005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 661005
Company Name: COSMEDENT, INC.

Primary DI Number: D7796610053
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113911689 *Terms of Use

Device Description: Porcelain Repair Kit (Green) includes 1 (2.5 cc) PorcelETCH™ Green, 3 of 25-gauge Blue Luer Lock Tips, 1 (10 mL) Bottle of Silanator™, 1 (3 g) GINGA-Guard syringe, 3 of White nozzle, 3 of 16 gauge Black Luer Lock Tips, 1 (2.5 g) Creative Color Opaquer Pink syringe, 1 Cosmedent #1 brush, and 1 (6 mL) Complete Primer/Unfilled Resin (Red Cap) in the Tray.

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:	Yes
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?
35877	Dental repair kit, ceramic	A packaged collection of devices used for the repair of fractured porcelain veneers. This kit is used by a dentist and may include etching gel or liquid, bonding material, silanization liquid, a polymer-based restorative material (composite) and several other devices. This is a single-use device.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
No Product Codes

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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e3bf4b76-a807-487b-8adf-d9ab7eebcf0b
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016