FDA.reportPublic FDA data

Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

Primary DI
06970010342268
Brand
Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Company
NISSIN METEC CHINA CO.,LTD.
Model
40×19×15 A2
Published
2017-07-24
Public version status
Update
Distribution status
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160367000Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankNissin-Metec China Co., Ltd.2016-07-27EIH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970010342275PackageGS110In Commercial Distribution
06970010348994PackageGS13In Commercial Distribution
06970010349007PackageGS15In Commercial Distribution
06970010342268PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970010342275069700103422756970010342275
06970010348994069700103489946970010348994
06970010349007069700103490076970010349007
06970010342268069700103422686970010342268

GMDN Terms#

Term, Definition table
TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Regulatory Flags#

DUNS number
543006823
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970010343265Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank40×19×15 A32017-07-24
06970010340202Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank20×14×15（T0）2017-05-26
06970010340226Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank20×19×15（T0）2017-05-26
06970010340240Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank40×14×15（T0）2017-05-26
06970010340264Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank40×19×15（T0）2017-05-26
06970010340288Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank55×19×16（T0）2017-05-26
06970010340301Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank75×36×16（T0）2017-05-26
06970010340325Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank75×36×22（T0）2017-05-26
06970010340349Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×10（T0）2017-05-26
06970010340363Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×12（T0）2017-05-26
06970010340387Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×14（T0）2017-05-26
06970010340400Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×16（T0）2017-05-26
06970010340424Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×18（T0）2017-05-26
06970010340448Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×20（T0）2017-05-26
06970010340462Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×22（T0）2017-05-26
06970010340486Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×24（T0）2017-05-26
06970010340509Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank76×40×26（T0）2017-05-26
06970010340523Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank70×40×10（T0）2017-05-26
06970010340547Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank70×40×12（T0）2017-05-26
06970010340561Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank70×40×14（T0）2017-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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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
D800FMAA05030Colour Liquid A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA06030Colour Liquid B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA07030Colour Liquid B2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA08030Colour Liquid B3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA09030Colour Liquid B4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA10030Colour Liquid C1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA11030Colour Liquid C2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA12030Colour Liquid C3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28