FDA.reportPublic FDA data

Restoration

Primary DI
06972677870054
Brand
Restoration
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
005
Device description
Porcelain restorations are full porcelain crown and bridge restorations that are manufactured as finished products from porcelains.
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
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677870054PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677870054069726778700546972677870054

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown, ceramicA device made totally of ceramic material, and created for a specific patient, 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
1
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
06977053950047ULTRATHINEERBMF Tech (Zhuhai) Inc.NSP2024-12-08
06977053950054ULTRATHINEERBMF Tech (Zhuhai) Inc.NSP2024-12-08
06977512700008DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700015DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
06977512700022DTS, RESTORATION, PORCELAINDTS Digital Dental LabNSP2024-06-13
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-18
08936214221301Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223022Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223084Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214221318Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-17
08936214221226Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-13
08936214221028RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-12