FDA.report

Tru-Stain

Primary DI
D8370129000
Brand
Tru-Stain
Company
Taub Products
Model
Yellow - 3 gm
Catalog number
01-2900
Device description
Tru-Stains are colored acrylic powder, that are applied by brush to modify the shades of provisional and permanent acrylic. The stains are applied to heat cured acrylic restorations.
Published
2016-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
EBDCoating, Filling Material, Resin

Product Code Classifications

CodeDeviceSpecialtyClass
EBDCoating, Filling Material, ResinDental2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D8370129000PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental crown/bridge resin, temporaryA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Device Sizes

TypeValueUnit
Weight3Gram

Storage And Handling

TypeLowHighCondition
Special Storage Condition, Specify00Keep away from open flame. See SDS.

Sterilization Methods

Method

Contacts

PhoneEmail
+1.201.798.5353customerservice@taubdental.com

Regulatory Flags

DUNS number
067488114
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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D8370720310Tru-PaqueDark Yellow - 50 mL07-20312023-06-26
D8370720400Tru-PaqueGray - 12 mL07-20402023-06-26
D8370720410Tru-PaqueGray - 50 mL07-20412023-06-26
D8370720500Tru-PaqueWhite - 12 mL07-20502023-06-26
D8370720510Tru-PaqueWhite - 50 mL07-20512023-06-26
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