FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214223190
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
318
Published
2022-10-18
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
08936214223183PrimaryGS10
08936214223190Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214223183089362142231838936214223183
08936214223190089362142231908936214223190

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
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
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
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
08936214223251Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-18
08936214221363Denture, Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-17
08936214223008Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSL2022-10-17