AccessGUDID - DEVICE: DTK adhesive refill pack (EBRE540011950)

GUDID

Device Identifier (DI) Information

Brand Name: DTK adhesive refill pack
Version or Model: 54001195
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 54001195
Company Name: bredent GmbH & Co. KG

Primary DI Number: EBRE540011950
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 341086190 *Terms of Use

Device Description: DTK adhesive refill pack in a double mixing cartridge 1 x 8 g

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?
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
KOL	ADHESIVE, DENTURE, CARBOXYMETHYLCELLULOSE SODIUM (32%) AND ETHYLENE-OXIDE HOMOPOLYMER

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes 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: e446629b-181c-40d3-a98d-9691f8c11f30
Public Version Date: March 29, 2018
Public Version Number: 2
DI Record Publish Date: September 22, 2016