FDA.reportPublic FDA data

NexxZr™ T / Z-95-25-NT-B300-SD

Primary DI
00842271106346
Brand
NexxZr™ T / Z-95-25-NT-B300-SD
Company
SAGEMAX BIOCERAMICS, INC
Model
Z-32085
Published
2023-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130991000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130991000NEXXZR(TM)T AND NEXXZR(TM)SSagemax Bioceramics, Inc.2014-02-10EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842271106346PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842271106346008422711063468422711063460842271106346

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

Regulatory Flags#

DUNS number
002265727
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814356023589NexxZr™ Plus / Z-95-22-NP-C300-SDZ-221282018-03-26
00814356023596NexxZr™ Plus / Z-95-25-NP-C300-SDZ-221292018-03-26
00814356023633NexxZr™ Plus / Z-95-10-NP-C400-SDZ-221332018-03-26
00814356023640NexxZr™ Plus / Z-95-12-NP-C400-SDZ-221342018-03-26
00814356023657NexxZr™ Plus / Z-95-14-NP-C400-SDZ-221352018-03-26
00814356023664NexxZr™ Plus / Z-95-16-NP-C400-SDZ-221362018-03-26
00814356023671NexxZr™ Plus / Z-95-18-NP-C400-SDZ-221372018-03-26
00814356023688NexxZr™ Plus / Z-95-20-NP-C400-SDZ-221382018-03-26
00814356023695NexxZr™ Plus / Z-95-22-NP-C400-SDZ-221392018-03-26
00814356023701NexxZr™ Plus / Z-95-25-NP-C400-SDZ-221402018-03-26
00814356023749NexxZr™ Plus / Z-95-10-NP-D200-SDZ-221442018-03-26
00814356023756NexxZr™ Plus / Z-95-12-NP-D200-SDZ-221452018-03-26
00814356023763NexxZr™ Plus / Z-95-14-NP-D200-SDZ-221462018-03-26
00814356023770NexxZr™ Plus / Z-95-16-NP-D200-SDZ-221472018-03-26
00814356023787NexxZr™ Plus / Z-95-18-NP-D200-SDZ-221482018-03-26
00814356023794NexxZr™ Plus / Z-95-20-NP-D200-SDZ-221492018-03-26
00814356023800NexxZr™ Plus / Z-95-22-NP-D200-SDZ-221502018-03-26
00814356023817NexxZr™ Plus / Z-95-25-NP-D200-SDZ-221512018-03-26
00814356023305NexxZr™ Plus / Z-95-10-NP-C100-SDZ-221002018-03-26
00814356023312NexxZr™ Plus / Z-95-12-NP-C100-SDZ-221012018-03-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06976581410009Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410016Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410023Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410030Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410047Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410054Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410061Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
06976581410078Dental Zirconia BlankHunan Haoci Material Technology Co., LtdEIH2026-06-06
EDDI963011DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963051DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963061DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963071DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963081DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963091DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963161DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963171DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963431DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963441DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963451DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963821DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963831DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963841DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963851DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963861DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963941DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963951DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963961DD cubeY® HLDental Direkt GmbHEIH2026-06-02
EDDI963971DD cubeY® HLDental Direkt GmbHEIH2026-06-02
D800FMAA01030Colour Liquid A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA04030Colour Liquid A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28