FDA.reportPublic FDA data

n!ce® Zirconia GT

Primary DI
J01701076350
Brand
n!ce® Zirconia GT
Company
Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft
Model
010.7635
Device description
n!ce® Zirconia GT, Multi D2, Ø 98.4 x h 30 mm (010.7635)
Published
2026-03-27
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
K243940000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243940000VITA YZ Multi TranslucentVita Zahnfabrik H.Rauter GmbH & Co.2025-02-21EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
J01701076350PrimaryHIBCC0

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.

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
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
J017EDCYM89830380VITA YZ® SOLUTIONSEDCYM89830382026-04-10
J017EDCYM89830390VITA YZ® SOLUTIONSEDCYM89830392026-04-10
J017EDCYM89830400VITA YZ® SOLUTIONSEDCYM89830402026-04-10
J017EDCYM89830410VITA YZ® SOLUTIONSEDCYM89830412026-04-10
J017EDCYM89830420VITA YZ® SOLUTIONSEDCYM89830422026-04-10
J017EDCYM89830430VITA YZ® SOLUTIONSEDCYM89830432026-04-10
J017EDCYM89830440VITA YZ® SOLUTIONSEDCYM89830442026-04-10
J017EDCYM89830450VITA YZ® SOLUTIONSEDCYM89830452026-04-10
J017EDCYM89830460VITA YZ® SOLUTIONSEDCYM89830462026-04-10
J017EDCYM89830470VITA YZ® SOLUTIONSEDCYM89830472026-04-10
J017EDCYM89830480VITA YZ® SOLUTIONSEDCYM89830482026-04-10
J017EDCYM89830490VITA YZ® SOLUTIONSEDCYM89830492026-04-10

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Primary DI, Brand, Company table
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