FDA.reportPublic FDA data

Denture, restoration, orthodontic

Primary DI
06972677874137
Brand
Denture, restoration, orthodontic
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
412
Published
2020-07-22
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
NSLDentures, Full

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677874120PrimaryGS10
06972677874137Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677874120069726778741206972677874120
06972677874137069726778741376972677874137

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, metal-polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy with a tooth-coloured polymer material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
551746187
Device count
4
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
06972677871648Senture, surgical guide1642020-07-21
06972677879989Denture,restoration,orthodontic,anti-snoring,orthodontic9982020-07-30
06972677870108Surgical Guide0102020-07-21
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810126380159Set Full DentureDigital Dental Laboratories, IncNSL2026-02-25
00810126380166Finish Full DentureDigital Dental Laboratories, IncNSL2026-02-25
06977512700046DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
06977512700091DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
D101SGI1590Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2024-04-05
D101SGI1490Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-12-21
D101SGI1250Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-12-05
D101SGI1460Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-09-12
D101SGI1430Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-06-01
D101SGI170Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-04-05
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223374Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224159Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223121Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223145Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223190Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214223251Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214221363Denture, Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-17