FDA.reportPublic FDA data

ENERGY CTZ1 CEMENT

Primary DI
D8375210000
Brand
ENERGY CTZ1 CEMENT
Company
Taub Products
Model
CLEAR - 5.4ML SYR
Catalog number
52-1000
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."
Published
2023-11-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EMACement, Dental

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EMACement, DentalDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132393000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132393000CERCOM II CEMENTDenali Corporation2014-03-14EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8375210000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental composite resinA 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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Total Volume5Milliliter
Total Volume5.4Milliliter
Weight7Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat. Refrigerate. See SDS.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1.201.798.5353customerservice@taubdental.com

Regulatory Flags#

DUNS number
067488114
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D8371320370Bright SpotIV - Dark Blue - 2 oz Btl13-20372026-07-23
D8371320400Bright SpotV - Lt. Green -15 mL13-20402026-07-23
D8371320500Bright SpotVI - Pink -15 mL13-20502026-07-23
D8371320520Bright SpotVI - Pink - 2 oz13-20522026-07-23
D8371340000Bright SpotThinner - 1 oz13-40002026-07-23
D8371340010Bright SpotThinner - 2 oz13-40012026-07-23
D8371320100Bright SpotII - Red -15 mL13-20102026-07-16
D8371320200Bright SpotIII - White - No Bond -15 mL13-20202026-07-16
D8371320300Bright SpotIV - Blue -15 mL13-20302026-07-16
D8371320350Bright SpotIV - Dark Blue -15 mL13-20352026-07-16
D8370650100FUSION-Zr - Veneer CementKit - 2 Crystal Clear - 1.2ml Syringe06-50102016-12-05
D8370650200FUSION-Zr - Veneer CementKit - 2 Opal White - 1.2ml Syringe06-50202016-12-05
D8370651050FUSION-Zr - Veneer CementCrystal Clear - 3ml Syringe06-51052016-12-05
D8370651150FUSION-Zr - Veneer CementOpal White - 3ml Syringe06-51152016-12-05
D8370655000FUSION-Zr - Veneer CementCrystal Clear - 0.6mL - Sample06-55002016-12-05
D8370655100FUSION-Zr - Veneer CementOpal White - 0.6mL - Sample06-55102016-12-05
D8370655200FUSION-Zr - Veneer CementNew White - 0.6mL - Sample06-55202016-12-05
D8374610000ZERO-G Bio Implant CementKit - 7 gm Syringe - 2pk46-10002016-12-05
D8374610050ZERO-G Bio Implant Cement7 gm Syringe - 1pc46-10052016-12-05
D8374650000ZERO-G Bio Implant Cement3.5 gm Syringe - Evaluator46-50002016-12-05

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Primary DI, Brand, Company table
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