FDA.reportPublic FDA data

JET TOOTH SHADE POWDER

Primary DI
D650142062TS0
Brand
JET TOOTH SHADE POWDER
Company
LANG DENTAL MANUFACTURING CO., INC.
Model
100 GRAN SHADE 62/A2
Catalog number
142062TS
Device description
FAST CURING PROVISIONAL CROWN & BRIDGE ACRYLIC RESIN POWDER
Published
2017-09-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
EBGCrown And Bridge, Temporary, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D650142062TS0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridge resinA material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
005185798
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D650PTA10PULSETEMPSHADE A1 50 ML CARTRIDGE 10:1PTA12026-01-15
D650PTA20PULSETEMPSHADE A2 50 ML CARTRIDGE 10:1PTA22026-01-15
D650PTA30PULSETEMPSHADE A3 50 ML CARTRIDGE 10:1PTA32026-01-15
D6500270C0ORTHO-JET CRYSTAL POWDER11.3 KG0270C2023-06-27
D6500934F10FLEXACRYL HARDPOUND PACKAGE F10934F12023-06-27
D6500950CLR0FLEXACRYL2.7 KG CLEAR0950CLR2023-06-27
D6501070P10TEMPO POWDER11.3 KG P11070P12023-06-27
D6501330LS0ORTHO-JET POWDER1 LB LOW SLUMP1330LS2023-06-27
D6501356PT0ORTHO-JETFIVE POUND PACKAGE PINK TINT1356PT2023-06-27
D6501480LI0JET TOOTH SHADE POWDER45.4 KG SHADE LIGHT INCISAL1480LI2023-06-27
D6504720F20JET SET-4 DENTURE REPAIR100 GRAM F24720F22022-10-20
D6504720P10JET SET-4 DENTURE REPAIR100 GRAM P14720P12022-10-20
D6504723F20JET SET-4 DENTURE REPAIRPROFESSIONAL PACKAGE F24723F22022-10-20
D6504723P10JET SET-4 DENTURE REPAIRPROFESSIONAL PACKAGE P14723P12022-10-20
D6504730F20JET SET-4 DENTURE REPAIR454 GRAM F24730F22022-10-20
D6504730P10JET SET-4 DENTURE REPAIR454 GRAMS P14730P12022-10-20
D6504734F20JET SET-4 DENTURE REPAIRPOUND PACKAGE F24734F22022-10-20
D6504734P10JET SET-4 DENTURE REPAIRPOUND PACKAGE P14734P12022-10-20
D65047H0F20JET SET-4 DENTURE REPAIR250 GRAMS F247H0F22022-10-20
D65047H0P10JET SET-4 DENTURE REPAIR250 GRAMS P147H0P12022-10-20

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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