FDA.reportPublic FDA data

JUVORA Dental Disc, Ceramill PEEK by JUVORA

Primary DI
07630031739582
Brand
JUVORA Dental Disc, Ceramill PEEK by JUVORA
Company
Institut Straumann AG
Model
Crowns
Catalog number
010.4121
Device description
CARES® single-unit restoration, JUVORA(TM) PEEK
Published
2019-08-23
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Conditional
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
K160918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160918000JUVORA Dental Disc, Ceramill PEEK by JUVORAJuvora2017-02-13EBI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630031739582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630031739582076300317395827630031739582

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(801)448-8168info.usa@straumann.com

Regulatory Flags#

DUNS number
483599259
Device count
1
Serial number
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630031711366NAPlan Abutments025.2602-042022-12-02
07630031711410NAPlan Abutments025.2612-042022-12-02
07630031711427NAPlan Abutments025.2613-042022-12-02
07630031711465NAPlan Abutments025.2621-042022-12-02
07630031712639NATransfer aids025.4913-042022-12-02
07630031722645NAPlan Abutments048.073V42022-12-02
07630031723000NAConventional impression048.122V42022-12-02
07630031723970NAPlan Abutments048.276V42022-12-02
07630031724021NAPlan Abutments048.283V42022-12-02
07630031724038NAPlan Abutments048.284V42022-12-02
07630031724045NAPlan Abutments048.285V42022-12-02
07630031724052NAPlan Abutments048.286V42022-12-02
07630031724069NAPlan Abutments048.287V42022-12-02
07630031734884N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71352023-08-24
07630031734921N!CE Glass Ceramic Blocks For Amann GirrbachMilling Materials010.71392022-04-14
07630031731012n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70522019-06-18
07630031731029n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70532019-06-18
07630031731050n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70562019-06-18
07630031731067n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70572019-06-18
07630031731081n!ce Glass Ceramic Blocks for Amann GirrbachMilling Materials010.70592019-06-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
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
EPOLPMMP10090Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10100Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10110Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10120Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17
EPOLPMMP10130Pink CAD/CAM DiscPOLIDENT d.o.o.EBI2024-10-17