AccessGUDID - DEVICE: ENERGY CTZ1 CEMENT (D8375210000)

GUDID

Device Identifier (DI) Information

Brand Name: ENERGY CTZ1 CEMENT
Version or Model: CLEAR - 5.4ML SYR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52-1000
Company Name: Taub Products

Primary DI Number: D8375210000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: ENERGY CTZ1 Cement is Dual Cure and self-adhesive, with 60 seconds of work time and fully set in 90 seconds. Excellent chemical bond to 3D Milled Zirconia, 3D Milled Ceramic, and 3D Printed "Ceramic" Resin restorations, Zirconia, Lithium Disilicate, Feldspathic Porcelain, Titanium, and Tooth Structure. It is used where a shorter set time is preferred and used for Long Term cementation of Single unit Zirconia, Ceramic, and 3D Printed "Ceramic" Resin Restorations to Titanium or Zirconia Abutments and similar restorations; Single unit Zirconia, Ceramic, and 3D Printed "Ceramic" Resin Restorations and other similar restorations to Tooth Structure; veneers, crown & bridge restorations, inlays/onlays, PFM, posts/fiber posts.

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:	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?
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 [?]
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
Special Storage Condition, Specify: Keep away from heat. Refrigerate. See SDS.

Clinically Relevant Size

[?]

Size Type Text
Weight: 7 Gram
Total Volume: 5.4 Milliliter

Device Record Status

Public Device Record Key: 211a43e5-e60c-4a04-a439-d0d6294e3c7e
Public Version Date: April 22, 2024
Public Version Number: 2
DI Record Publish Date: November 02, 2023