FDA.reportPublic FDA data

VITA CAD Temp

Primary DI
J017EN1CA220192100
Brand
VITA CAD Temp
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
EN1CA22019210
Device description
VITA CAD-Temp multiColor Universal, 3M2T, CTM-40, 10 pcs.
Published
2017-02-18
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EBGCROWN AND BRIDGE, TEMPORARY, RESIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EBGCrown And Bridge, Temporary, ResinDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K070991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K070991000VITA CAD-TEMP FOR INLAB, MODEL, VX59-4002, VX59-4010, VX59-4102, VX59-4110, VX59-4202, VX59-4210, VX59-4302, VX59-4310Vita2007-06-01EBG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J017EN1CA220192100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Temporary dental crown/bridgeA prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)8283839info@vitanorthamerica.com

Regulatory Flags#

DUNS number
315165357
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
J017BLSKCV20VITA LUMEX® ACBLSKCV22026-09-24
J017BLSKV20VITA LUMEX® ACBLSKV22026-09-24
J017BLSTKCV20VITA LUMEX® ACBLSTKCV22026-09-24
J017BV13BK12CV50VITA VM®13BV13BK12CV52026-09-24
J017BV13BK12V50VITA VM®13BV13BK12V52026-09-24
J017BV13BKS12V50VITA VM®13BV13BKS12V52026-09-24
J017BV13GKV20VITA VM®13BV13GKV22026-09-24
J017BV13MKV20VITA VM®13BV13MKV22026-09-24
J017BV9GKV20VITA VM®9BV9GKV22026-09-24
J017BV9MKV20VITA VM®9BV9MKV22026-09-24
J017BVMKSETCV30VITA VMK Master®BVMKSETCV32026-09-24
J017LAMSKCV20VITA AMBRIA®LAMSKCV22026-09-24
J017CVMLP0140VITA VM®LCCVMLP0142026-05-07
J017CVMLP0240VITA VM®LCCVMLP0242026-05-07
J017CVMLPSET0VITA VM®LCCVMLPSET2026-05-07
J017EDCYM89830020VITA YZ® SOLUTIONSEDCYM89830022026-04-10
J017EDCYM89830030VITA YZ® SOLUTIONSEDCYM89830032026-04-10
J017EDCYM89830040VITA YZ® SOLUTIONSEDCYM89830042026-04-10
J017EDCYM89830360VITA YZ® SOLUTIONSEDCYM89830362026-04-10
J017EDCYM89830370VITA YZ® SOLUTIONSEDCYM89830372026-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06942201762285FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762377FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201762476FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774288FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774387FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774479FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774578FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774769FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774950FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774967FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201774981FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775056FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775155FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775179FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775230FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775247FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775339FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775346FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775438FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775537FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201775728FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-09-05
06942201760748FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760946FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201760960FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761035FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761134FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761158FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761219FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761226FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28
06942201761325FLNT TempLiaoning Upcera Co.,Ltd.EBG2026-07-28