FDA.reportPublic FDA data

Zirlux

Primary DI
00304040151549
Brand
Zirlux
Company
HENRY SCHEIN, INC.
Model
9012706
Catalog number
9012706
Device description
ZIRLUX ACETAL MILLING DISC
Published
2021-03-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
K172407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172407000DuracetalThe Myerson Company Limited2017-11-02EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00304040151549PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00304040151549003040401515493040401515490304040151549

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Height25Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0193 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
012430880
Device count
1
DM exempt
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00304040194348Henry Schein570569157056912025-12-15
00304040194355Henry Schein570569357056932025-12-15
00304040194362Henry Schein570569057056902025-12-15
00304040194386Henry Schein570570957057092025-12-15
10304040193362Henry Schein570560057056002026-06-25
10304040194048Essentials570567957056792026-06-25
10304040194055Essentials570567557056752026-06-25
10304040194062Essentials570567657056762026-06-25
10304040194079Essentials570567757056772026-06-25
10304040194086Essentials570567857056782026-06-25
00304040007426Henry Schein101700410170042016-09-24
00304040007433Henry Schein900417190041712016-09-24
00304040007440Henry Schein101562310156232016-09-24
00304040007457Henry Schein101562410156242016-09-24
00304040007464Henry Schein900419290041922016-09-24
00304040007471Henry Schein900419390041932016-09-24
10304040196974Henry Schein570586457058642026-05-14
10304040196981Henry Schein570586557058652026-05-14
10304040196998Henry Schein570586657058662026-05-14
10304040197001Henry Schein570586757058672026-05-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07615208585728Ivotion BaseIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585735IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585742IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585759IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585766IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585773IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
07615208585780IvotionIVOCLAR VIVADENT AKTIENGESELLSCHAFTEBI2026-07-08
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
D14307560147448040Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448110Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448280Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147448350Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147449650Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
D14307560147450090Smart Dent ®MMTECH PROJETOS TECNOLOGICOS IMPORTACAO E EXPORTACAO LTDA.EBI2026-05-29
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
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