AccessGUDID - DEVICE: Complete Bonding Kit (D7796540053)

GUDID

Device Identifier (DI) Information

Brand Name: Complete Bonding Kit
Version or Model: 654005
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 654005
Company Name: COSMEDENT, INC.

Primary DI Number: D7796540053
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 113911689 *Terms of Use

Device Description: Complete Bonding Kit includes 1 bottle of Primer/Unfilled Resin, 1 bottle of Dual-Cure Catalyst, 1 bottle of Unfilled Resin, one #1 brush/straight; and one #1 brush/bent in 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?
44725	Dental composite adhesive kit	A collection of devices intended to be used to bond attachments such as hooks or buttons to the teeth and/or to an orthodontic aligner during dental or orthodontic teeth adjustment. The adhesives are typically based on light-cured bonding composites (e.g., 400-500nm range). The contents of this kit may include etchant, bonding resin, bonding paste, spatula, brushes, and a paper pad. This is a reusable 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: 096775dc-2463-42f1-8e8f-8dd7cb1a71dc
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016