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
07630031736451Straumann BoneceramicBoneCeramic070.1982022-04-01
07630031736468Straumann BoneceramicBoneCeramic070.1992022-04-01
07630031736475Straumann BoneceramicBoneCeramic070.2002022-04-01
07630031700155STRAUMANN GRANULESBoneCeramic070.2032015-09-24
07630031700162STRAUMANN GRANULESBoneCeramic070.2042015-09-24
07630031700179STRAUMANN GRANULESBoneCeramic070.2052015-09-24
07630031739575NAAnatomic drill guides010.40212022-11-10
07630031755537CoDiagnostiXAnatomic drill guides010.40302022-04-29
07630031739933Surgical Guide - 3D Printed Model2017010.40212018-07-19
07630031764263Straumann® BLC Implants - Indication WideningSLA Roxolid BL035.8218S2023-11-04
07630031764331Straumann® BLC Implants - Indication WideningSLActive Roxolid BL035.9218S2023-11-04
07630031778086NAsurgically Invasive Instruments066.50632026-06-03
07630031778093NAsurgically Invasive Instruments066.50642026-06-03
07630031778109NAsurgically Invasive Instruments066.50652026-06-03
07630031778116NAsurgically Invasive Instruments066.50662026-06-03
07630031778123NAsurgically Invasive Instruments066.50672026-06-03
07630031778130NAsurgically Invasive Instruments066.50682026-06-03
07630031778147NAsurgically Invasive Instruments066.50692026-06-03
07630031778154NAsurgically Invasive Instruments066.50702026-06-03
07630031778161NAsurgically Invasive Instruments066.50712026-06-03

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Primary DI, Brand, Company table
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00842326128149DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128156DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128163DuraflexThe Myerson Company LimitedEBI2026-10-22
00842326128170DuraflexThe Myerson Company LimitedEBI2026-10-22
06942480719550FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480719567FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720396FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720402FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480720617FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
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06942480721454FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480721461FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722284FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722291FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722505FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480722512FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723335FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
06942480723342FLNT BaseLiaoning Upcera Co.,Ltd.EBI2026-10-19
00810222900206SprintRay Crown HT A1 Single-Unit Capsule - JapanSprintray, Inc.EBI2026-10-09
00810222900213SprintRay Crown HT A2 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900220SprintRay Crown HT Bleach Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900237SprintRay Crown HT B1 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900244SprintRay Crown HT B1 Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900251SprintRay Crown HT Bleach Single-Unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900268SprintRay Crown HT A3 Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
00810222900275SprintRay Crown HT A3 Single-unit Capsule 3-Pack - JPSprintray, Inc.EBI2026-10-09
00810222900282SprintRay Crown HT Unpigmented Single-Unit Capsule - JPSprintray, Inc.EBI2026-10-09
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