FDA.reportPublic FDA data

FUSION-Zr - Veneer Cement

Primary DI
D8370655000
Brand
FUSION-Zr - Veneer Cement
Company
Taub Products
Model
Crystal Clear - 0.6mL - Sample
Catalog number
06-5500
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.
Published
2016-12-05
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
K073101000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K073101000AURAVENEER CEMENTDenali Corporation2008-01-17EMA

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8370655000PrimaryHIBCC0

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 Volume0.6Milliliter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from heat. Store at room temperature. 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
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
D8374710000Liquid Magic - Resin BarrierKit - 3 mL Syr - 2 pk47-10002016-12-05

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