FDA.reportPublic FDA data

NexxZr® T Multi / W-98-16-NT-C200-MT

Primary DI
00842271175441
Brand
NexxZr® T Multi / W-98-16-NT-C200-MT
Company
SAGEMAX BIOCERAMICS, INC
Model
745458
Published
2021-04-01
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
00842271175441PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842271175441008422711754418422711754410842271175441

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842271158666NexxZr Plus Multi 2.0 B3 W98-20mm7603872024-03-20
00842271158673NexxZr Plus Multi 2.0 B4 W98-20mm7603882024-03-20
00842271158680NexxZr Plus Multi 2.0 C1 W98-20mm7603892024-03-20
00842271158697NexxZr Plus Multi 2.0 C2 W98-20mm7603902024-03-20
00842271158703NexxZr Plus Multi 2.0 C3 W98-20mm7603912024-03-20
00842271158710NexxZr Plus Multi 2.0 C4 W98-20mm7603922024-03-20
00842271158727NexxZr Plus Multi 2.0 D2 W98-20mm7603932024-03-20
00842271158734NexxZr Plus Multi 2.0 D3 W98-20mm7603942024-03-20
00842271158741NexxZr Plus Multi 2.0 D4 W98-20mm7603952024-03-20
00842271158192NexxZr Plus Multi 2.0 A1 W98-14mm7603402024-03-19
00842271158208NexxZr Plus Multi 2.0 A2 W98-14mm7603412024-03-19
00842271158215NexxZr Plus Multi 2.0 A3 W98-14mm7603422024-03-19
00842271158222NexxZr Plus Multi 2.0 A3.5 W98-14mm7603432024-03-19
00842271158239NexxZr Plus Multi 2.0 A4 W98-14mm7603442024-03-19
00842271158246NexxZr Plus Multi 2.0 B1 W98-14mm7603452024-03-19
00842271158253NexxZr Plus Multi 2.0 B2 W98-14mm7603462024-03-19
00842271158260NexxZr Plus Multi 2.0 B3 W98-14mm7603472024-03-19
00842271158277NexxZr Plus Multi 2.0 B4 W98-14mm7603482024-03-19
00842271158284NexxZr Plus Multi 2.0 C1 W98-14mm7603492024-03-19
00842271158291NexxZr Plus Multi 2.0 C2 W98-14mm7603502024-03-19

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
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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
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06941382286856Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
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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