AccessGUDID - DEVICE: FUSION-Zr - Veneer Cement (D8370650200)

GUDID

Device Identifier (DI) Information

Brand Name: FUSION-Zr - Veneer Cement
Version or Model: Kit - 2 Opal White - 1.2ml Syringe
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 06-5020
Company Name: Taub Products

Primary DI Number: D8370650200
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: FUSION-Zr™ is a self-adhesive, light cure veneer cement and is indicated for the adhesive cementation of all-ceramic restorations, Feldspathic Porcelain, Lithium Disilicate and CAD/CAM type materials, where light curing is desired.

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:	Yes
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?
35870	Dental composite resin	A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EMA	Cement, Dental

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K073101	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 heat. Store at room temperature. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Total Volume: 1.2 Milliliter

Device Record Status

Public Device Record Key: 77a02f74-9714-40a6-b08e-09a3dbbce188
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: December 05, 2016