ENERGY CTZ1 CEMENT

Basic Information

• Brand Name: ENERGY CTZ1 CEMENT
• Primary DI: D8375210000
• Version / Model: CLEAR - 5ML SYR
• Catalog Number: 52-1000
• Company Name: Taub Products
• Labeler DUNS: 067488114
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-11-02
• Public Version: 1
• Public Version Date: 2023-11-10
• Public Version Status: New
• Public Device Record Key: 211a43e5-e60c-4a04-a439-d0d6294e3c7e

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

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EMA	Cement, Dental	Dental	872.3275	2

GMDN Terms

Code	Name	Definition	Implantable	Status
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.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	D8375210000	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K132393	000

Device Sizes

Type	Value	Unit	Text
Weight	7	Gram
Total Volume	5	Milliliter

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: Keep away from heat. Refrigerate. See SDS.