FDA.reportPublic FDA data

Denture, restoration, splint

Primary DI
06972677874182
Brand
Denture, restoration, splint
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
418
Published
2020-07-22
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
NSLDentures, Full
NSORestoration, Porcelain-Fused-To-Metal
NSRProsthesis, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSJRestoration, Noble MetalUnknownN
NSLDentures, FullUnknownN
NSORestoration, Porcelain-Fused-To-MetalUnknownN
NSRProsthesis, OrthodonticUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677874182PrimaryGS10
06972677874199Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677874182069726778741826972677874182
06972677874199069726778741996972677874199

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
551746187
Device count
4
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
06972677870245ZenSplintModern Dental Laboratory (DG) Co., Ltd.NSR2026-04-28
D101SGI1460Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-09-12
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
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
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
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 LIMITEDNSL2022-10-20
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 LIMITEDNSL2022-10-20
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