FDA.reportPublic FDA data

STELLAR DC Acrylic

Primary DI
D8375010600
Brand
STELLAR DC Acrylic
Company
Taub Products
Model
Tooth White A1 - 5.85 gm Syringe
Catalog number
50-1060
Device description
STELLAR DC Acrylic Tooth White is a dual cure acrylic that light cures in 20 seconds and self cures in 120 seconds. Used for All-on-X pick-up and conversions, build up esthetic PMMA Tooth structure, Implant Verification Jigs, Indexes. Create Pickup Impression Copings. Position misaligning implant components during seating. Connect or fix single implant parts for soldering and welding.
Published
2019-03-19
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
EBHMaterial, Impression Tray, Resin
EKODenture Preformed (Partially Prefabricated Denture)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBHMaterial, Impression Tray, ResinDental1
EKODenture Preformed (Partially Prefabricated Denture)Dental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D8375010600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental acrylic resinA non-sterile substance intended for professional use as a dental cement, luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, typically for short-term fixed prosthesis use (temporary crowns and bridges used for 6 months or less) or long-term removable prosthesis use. It consists of a self-, light-, or dual-curing acrylic resin material [e.g., polymethylmethacrylate (PMMA)]; it does not include any additional hardening fillers/components. 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
Weight5.85Gram

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Extremely light sensitive. Keep original cap on syringe directly before and after use. Keep 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
Premarket exempt
true
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
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
D8374710000Liquid Magic - Resin BarrierKit - 3 mL Syr - 2 pk47-10002016-12-05
D8374750000Liquid Magic - Resin Barrier1.5 mL Syr - Evaluator47-50002016-12-05
D8374810000Go-CHx Gel - 0.8% ChlorhexidineKit - 3 mL Syr - 2 pk48-10002016-12-05
D8374810050Go-CHx Gel - 0.8% Chlorhexidine3 mL Syr - 1ea.48-10052016-12-05
D8374850000Go-CHx Gel - 0.8% Chlorhexidine0.6 mL Syr - 1ea - Evaluator48-50002016-12-05
D8375210050ENERGY CTZ1 CEMENTWHITE - 5.4ML SYR52-10052025-07-14
D8375010500STELLAR DC AcrylicTooth White A2 - 5.85 gm Syringe50-10502019-03-19
D8375010100STELLAR DC AcrylicPink - 5.85 gm Syringe50-10102018-06-01
D8375050000STELLAR DC AcrylicPink - 5.85 gm Syringe Eval50-50002018-09-26
D8375210000ENERGY CTZ1 CEMENTCLEAR - 5.4ML SYR52-10002023-11-02

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