FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214224142
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
414
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
NSNRestoration, Resin, Crown And Bridge
NSORestoration, Porcelain-Fused-To-Metal
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN
NSNRestoration, Resin, Crown And BridgeUnknownN
NSORestoration, Porcelain-Fused-To-MetalUnknownN
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214224142PrimaryGS10
08936214224159Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214224142089362142241428936214224142
08936214224159089362142241598936214224159

GMDN Terms#

Term, Definition table
TermDefinition
Complete lower dentureA custom-made artificial replacement for all teeth in the lower jaw (mandible) 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
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
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
D101SGI1460Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-09-12
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSN2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214223367Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20