FDA.reportPublic FDA data

NexxZr™ / W-98-20-UT-B300-ML

Primary DI
00842271139016
Brand
NexxZr™ / W-98-20-UT-B300-ML
Company
SAGEMAX BIOCERAMICS, INC
Model
W-103083
Published
2017-03-17
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
EIHPowder, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842271139016PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842271139016008422711390168422711390160842271139016

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
06941382286740Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286757Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286764Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286771Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286788Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286795Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286801Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286818Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286825Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286832Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286849Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286856Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286863Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286870Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286887Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286894Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286900Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286917Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286924Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286931Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286948Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286955Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286962Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286979Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286986Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286993Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287006Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287013Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287020Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287037Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20