FDA.reportPublic FDA data

Denture, restoration

Primary DI
06972677871198
Brand
Denture, restoration
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
118
Published
2020-07-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
NSJRestoration, Noble Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSJRestoration, Noble MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677871181PrimaryGS10
06972677871198Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677871181069726778711816972677871181
06972677871198069726778711986972677871198

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
2
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
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
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
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
08936214224135Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214224173Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214225019Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-20
08936214223121Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223282Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223138Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223176Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223237RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214223299Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-18
08936214221240Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSJ2022-10-17