FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214223367
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
336
Published
2022-10-20
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
NSLDentures, Full
NSPRestoration, Porcelain
NSQRestoration, Base Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN
NSPRestoration, PorcelainUnknownN
NSQRestoration, Base MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214223367PrimaryGS10
08936214223374Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214223367089362142233678936214223367
08936214223374089362142233748936214223374

GMDN Terms#

Term, Definition table
TermDefinition
Complete upper dentureA custom-made artificial replacement for all teeth in the upper jaw (maxilla) carried on a removable plate or frame which is supported by surrounding soft and hard tissues of the oral cavity. It can be made of a variety of materials including polymers [polymethylmethacrylate (PMMA), polycarbonate (PC)], acrylic, ceramics, and/or metals [e.g., base metal alloys or titanium (Ti)].

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
673251143
Device count
3
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
08936214221028Restoration1022022-10-12
08936214221066Restoration1062022-10-12
08936214221080Denture, Restoration 1082022-10-12
08936214221103Denture, Restoration 1102022-10-12
08936214221127Denture, Restoration 1122022-10-12
08936214221141Restoration 1142022-10-12
08936214221165Restoration 1162022-10-12
08936214221189Denture, Restoration 1182022-10-13
08936214221202Denture, Restoration 1202022-10-13
08936214221226Denture, Restoration 1222022-10-13
08936214221240Restoration 1242022-10-17
08936214221264Denture, Restoration 1262022-10-17
08936214221288Restoration1282022-10-17
08936214221301Restoration 1302022-10-17
08936214221325Denture, Restoration 1322022-10-17
08936214221349Restoration 1342022-10-17
08936214221363Denture, Surgical guide1362022-10-17
08936214223008Denture, Restoration 3002022-10-17
08936214223022Denture, Restoration 3022022-10-17
08936214223046Restoration3042022-10-17

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
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
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 LIMITEDNSQ2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSQ2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20