AccessGUDID - DEVICE: Xeno® IV Dual Cure Self-Etching Dental Adhesive (D0026680121)

GUDID

Device Identifier (DI) Information

Brand Name: Xeno® IV Dual Cure Self-Etching Dental Adhesive
Version or Model: 668012
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 668012
Company Name: DENTSPLY INTERNATIONAL INC.

Primary DI Number: D0026680121
Issuing Agency: HIBCC
Commercial Distribution End Date: October 28, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 083235549 *Terms of Use

Device Description: Xeno® IV Dual Cure Self-Etching Dental Adhesive Evaluator Package

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:	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?
16658	Dental impression material adhesive	A liquid material specifically made to give adhesion of an impression material to the impression tray. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
KLE	AGENT, TOOTH BONDING, RESIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K041343	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
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 2 Milliliter
Device Size Text, specify: SC Activator 2mL, XENO IV 2mL, 50 Flocked Applicator Tips, and 1 Mixing Well

Device Record Status

Public Device Record Key: f422e8f7-7f2c-4f33-a353-e8f01a7b6256
Public Version Date: October 03, 2022
Public Version Number: 4
DI Record Publish Date: September 21, 2016