FDA.reportPublic FDA data

VITA ENAMIC

Primary DI
J017EN1EM42826450
Brand
VITA ENAMIC
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
EN1EM4282645
Device description
VITA ENAMIC® UNIVERSAL, 4M2-HT, EM-10, 5 pcs.
Published
2024-02-15
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
K122269000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K122269000ENAMICVita Zahnfabrik H.Rauter GmbH & Co.2012-12-13EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J017EN1EM42826450PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, ceramicA dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.

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
00817724020500Luxisse+HEANY INDUSTRIES, INC.EIH2019-12-23
00817724020326Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020333Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020340Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020357Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020364Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020371Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020388Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020395Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020401Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020418Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020425Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020432Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020449Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020456Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020463Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020470Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020487Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020494Luxisse+HEANY INDUSTRIES, INC.EIH2019-11-01
00817724020036Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020043Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020050Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020067Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020074Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020081Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020098Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020104Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020111Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020128Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31
00817724020135Luxisse+HEANY INDUSTRIES, INC.EIH2019-10-31