ORTHO-JET CRYSTAL LIQUID

Primary DI
D6500204C0
Brand
ORTHO-JET CRYSTAL LIQUID
Company
LANG DENTAL MANUFACTURING CO., INC.
Model
236 ML
Catalog number
0204C
Device description
FAST CURING EXTRA CLEAR ORTHODONTIC ACRYLIC RESIN LIQUID
Published
2016-09-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
EBIResin, Denture, Relining, Repairing, Rebasing

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBIResin, Denture, Relining, Repairing, RebasingDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112397000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112397000ORTHO-JET CRYSTALLang Dental Mfg. Co., Inc.2011-11-04EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D6500204C0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental prosthesis restorative material, unfilled resinA material designed to repair dental prostheses that consists of an unfilled polymeric resin. The material works as a bonding agent to provide a strong and long-lasting attachment to the segments of a broken or cracked prosthesis; it typically consists of a single or two-component polymeric (e.g., acrylic) resin that usually becomes a solid polymer when treated with light and/or heat. The material is used in a dentist?s office or dental laboratory to repair fixed dental prostheses and/or partial or total dentures.

Regulatory Flags#

DUNS number
005185798
Device count
1
Lot or batch
true
Expiration date on label
true

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
D6501508YEL0CONTEMPORARY ORTHO-JET LIQUID19 L YELLOW1508YEL2017-12-01
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
D65038H0DRK0JET SET-4 TOOTH SHADE POWDER250 GRAMS SHADE DARK38H0DRK2016-09-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
07701126631194Opti-Cryl Pour Acrylic Original X 22 lbPRODUCTORA Y COMERCIALIZADORA ODONTOLOGICA NEW STETIC S AEBI2026-04-23
EPRC66100851dima Print Denture Base 2pro3dure medical GmbHEBI2025-07-31
08435288443584IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443591IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443614IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443645IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443669IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443690IDODENTINEUNION DENTAL SAEBI2025-07-30
08435288443607IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443621IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443638IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443652IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443676IDODENTINEUNION DENTAL SAEBI2024-11-27
08435288443683IDODENTINEUNION DENTAL SAEBI2024-11-27
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EPOLPMMP10140Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
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EPOLPMMP10160Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10170Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
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