FDA.reportPublic FDA data

NexxZr™ Plus / Z-95-10-NP-C300-SD

Primary DI
00814356023527
Brand
NexxZr™ Plus / Z-95-10-NP-C300-SD
Company
SAGEMAX BIOCERAMICS, INC
Model
Z-22122
Device description
https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=678281#deviceRecordKey=677511#
Published
2018-03-26
Public version status
Update
Distribution status
Not 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
00814356023527PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814356023527008143560235278143560235270814356023527

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
00842271175304NexxZr T Multi7454447454442026-08-25
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
01694207545069BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423619BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423626BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423633BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423640BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423657BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423664BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423671BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423688BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423695BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423701BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423718BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423725BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423732BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423749BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423756BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423763BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423770BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423787BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423794BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423800BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423817BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423824BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423831BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423848BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423855BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423862BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423879BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423886BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25
06942075423893BloomdenBloomden Bioceramics (Hunan) Co., Ltd.EIH2026-10-25