FDA.reportPublic FDA data

Nissin Dental Zirconia Blank & Dental Zirconia Pre

Primary DI
06970010347614
Brand
Nissin Dental Zirconia Blank & Dental Zirconia Pre
Company
NISSIN METEC CHINA CO.,LTD.
Model
70×40×18（B2）
Published
2017-07-13
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
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
06970010347614PackageGS12In Commercial Distribution
06970010347607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970010347614069700103476146970010347614
06970010347607069700103476076970010347607

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
543006823
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
false
Expiration date on label
true
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
06970010342268Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank40×19×15 A22017-07-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
D800FMAA13030Colour Liquid C4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA14030Colour Liquid D2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA15030Colour Liquid D3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA16030Colour Liquid D4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA17030Set Colour Liquid (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA19030Colour Liquid Thinner (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA20030Colour Liquid Stabilizer (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31020Colour Liquid Prettau A1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA31030Colour Liquid Prettau A1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32020Colour Liquid Prettau A2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA32030Colour Liquid Prettau A2 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33020Colour Liquid Prettau A3 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA33030Colour Liquid Prettau A3 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34020Colour Liquid Prettau A3,5 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA34030Colour Liquid Prettau A3,5 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35020Colour Liquid Prettau A4 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA35030Colour Liquid Prettau A4 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36020Colour Liquid Prettau B1 (100 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA36030Colour Liquid Prettau B1 (20 ml)ZIRKONZAHN SRLEIH2026-05-28
D800FMAA37020Colour Liquid Prettau B2 (100 ml)ZIRKONZAHN SRLEIH2026-05-28