FDA.reportPublic FDA data

VITA AMBRIA

Primary DI
J017LAM040S04350
Brand
VITA AMBRIA
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
LAM040S0435
Catalog number
LAM040S0435
Device description
VITA AMBRIA®, B3-HT, S, 5 pcs.
Published
2021-11-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193436000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193436000VITA AmbriaVita Zahnfabrik GmbH H Rauter & CO2020-05-14EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J017LAM040S04350PrimaryHIBCC0

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
J01753654500400CEREC MTL Speed53654500402026-11-05
J01753654500410CEREC MTL Speed53654500412026-11-05
J01753654500420CEREC MTL Speed53654500422026-11-05
J01753654500430CEREC MTL Speed53654500432026-11-05
J01753654500440CEREC MTL Speed53654500442026-11-05
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
J01753654500400CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500410CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500420CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500430CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
J01753654500440CEREC MTL SpeedVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftEIH2026-11-05
06942686762299Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
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06942686762329Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762336Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762343Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
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06942686762480Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762497Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762503Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
06942686762510Zirconia Dental CeramicsChengdu Besmile Medical Technology Co., Ltd.EIH2026-11-02
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