AccessGUDID - DEVICE: ENERGY CTZ3 CEMENT (D8375210600)

GUDID

Device Identifier (DI) Information

Brand Name: ENERGY CTZ3 CEMENT
Version or Model: WHITE A2 - 5.4ML SYR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52-1060
Company Name: Taub Products

Primary DI Number: D8375210600
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 067488114 *Terms of Use

Device Description: ENERGY CTZ3 Cement is Dual Cure and self-adhesive, with 3+ minutes of work time and fully set in 8 minutes. Excellent chemical bond to 3D Milled Zirconia, 3D Milled Ceramic, and 3D Printed "Ceramic" restorations, Zirconia, Standard Ceramics, Titanium, and Tooth Structure. It is used when a longer work time is preferred and used for the long-term cementation of multi-unit, all-ceramic and Zirconia Restorations to Zirconia Full Arch Denture Finals and other similar restorations; Cementing Titanium Abutments and Titanium Bars to Zirconia Full Arch Denture Finals and other similar restorations; Cementing Zirconia and Ceramic Restorations to Tooth Structure.

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: 2596d173-1f3e-440e-b3f5-d4379e2da58d
Public Version Date: April 22, 2024
Public Version Number: 2
DI Record Publish Date: November 02, 2023