FDA.reportPublic FDA data

Restoration

Primary DI
06972677871044
Brand
Restoration
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
104
Published
2020-07-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
NSJRestoration, Noble Metal
NSORestoration, Porcelain-Fused-To-Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSJRestoration, Noble MetalUnknownN
NSORestoration, Porcelain-Fused-To-MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677871044PrimaryGS10
06972677871051Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677871044069726778710446972677871044
06972677871051069726778710516972677871051

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, metal/ceramicA device made of a combination of metal and tooth-coloured ceramic, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
551746187
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972677870245ZenSplint0242026-04-28
06972677870214Trioclear System S,H2023-09-04
06972677870221Trioclear SystemS2023-09-04
06972677870238Trioclear SystemH2023-09-04
06972677871129Denture, splint1122020-07-21
06972677871143Anti-snoring, splint1142020-07-21
06972677871167Anti-snoring, splint1162020-07-21
06972677871242Restoration, splint1242020-07-21
06972677871341Restoration, splint1342020-07-21
06972677871402Restoration, splint1402020-07-21
06972677871525Denture, splint1522020-07-21
06972677871587Restoration, splint1582020-07-21
06972677871761Pink EF Series,Retainer1762022-08-26
06972677871785Blue Series,Splint1782022-08-26
06972677871808Pink Series,Splint1802022-08-26
06972677871846Pink EF Series,Splint1842022-08-26
06972677873147Restoration, orthodontic3142020-07-24
06972677873161Denture, splint3162020-07-24
06972677873222Anti-snoring, denture, splint3222020-07-24
06972677873246Anti-snoring, denture, splint3242020-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDDTS Digital Dental LabNSO2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2023-02-20
08936214229994Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223312Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223336RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224012Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224036Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224074Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224098Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224111Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20