FDA.reportPublic FDA data

Violet Tinted Monomer

Primary DI
D851X0
Brand
Violet Tinted Monomer
Company
JBC and Company
Model
X
Catalog number
X
Device description
Tinted Liquid
Published
2018-09-15
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K974727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K974727000JET ACRYLIC LIQUID-MONOMER, ORTHO JET POWDER-POLYMER, PLASTICIZED METHACRYLATE HOMOPOLYMER, METHACRYLATE COPOLYMER, METRJ.B.C and Co.1998-02-24EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
D851X0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, curedA resin that polymerizes under heat (heat-cured), light (light-cured), and/or after a period of time (self-cured) intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture base, occlusal splint/night guard); it may in addition be intended to fabricate non-patient-worn devices (e.g., drilling templates using 3-D printing). It consists of a reactive component (e.g., acrylic monomer, reactive polymer) that hardens via polymerization [or vulcanization]. Reinforcing fillers may be included in the resin to increase its strength and/or durability. After application, this material cannot be refabricated.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
830-685-3700info@jbcandcompany.com

Regulatory Flags#

DUNS number
080390783
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
D85101Luminary Red Polymer112018-09-15
D85102Luminary Pink Polymer222018-09-15
D85103Luminary Coral Red Polymer332018-09-15
D85104Luminary Orange Polymer442018-09-15
D85105Luminary Blaze Yellow Polymer55-22018-09-15
D85106Luminary Yellow Polymer662018-09-15
D85107Luminary Green Polymer772018-09-15
D85108Luminary Teal Polymer8082018-09-15
D85109Luminary Blue Polymer992018-09-15
D85110Luminary Blueberry Polymer10102018-09-15
D85111Luminary Purple Polymer11112018-09-15
D85112Luminary Chartreuse Polymer12122018-09-15
D851122TEAL0122 Teal Tinted Monomer122Teal122Teal2018-09-15
D851123MAROON0123 Maroon Tinted Monomer123Maroon123Maroon2018-09-15
D85113Black Onyx Tinted Monomer13132018-09-15
D85114Royal Red Polymer14142018-09-15
D85114SLATE0Slate Polymer14Slate14Slate2018-09-15
D85115Royal Pink Polymer15152018-09-15
D85116Royal Coral Red Polymer16162018-09-15
D85117Royal Orange Polymer17172018-09-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
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07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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07615208585797IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585803IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585810IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585827IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585834IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585841IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
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D14307560147450160Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147451840Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
07615208482775ProBase Hot / ProBase ColdIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-04-30
08056640078369major.base 20MAJOR PRODOTTI DENTARI SPAEBI2026-04-27
08056640078857major.repairMAJOR PRODOTTI DENTARI SPAEBI2026-04-27
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