FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214223268
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
326
Published
2022-10-18
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
NSKDentures, Partial
NSORestoration, Porcelain-Fused-To-Metal
NSPRestoration, Porcelain

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSKDentures, PartialUnknownN
NSORestoration, Porcelain-Fused-To-MetalUnknownN
NSPRestoration, PorcelainUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214223268PrimaryGS10
08936214223275Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214223268089362142232688936214223268
08936214223275089362142232758936214223275

GMDN Terms#

Term, Definition table
TermDefinition
Partial dentureA custom-made, removeable, artificial replacement for one or more, but not all, teeth in the lower or upper jaw (mandible or maxilla) in a partially edentulous patient. It typically includes clasps of metal or plastic that clip onto remaining teeth for retention and stabilization. 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)]. Also known as a removable partial denture (RPD).

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
00810126380173Finish Denture - 1-3 TeethDigital Dental Laboratories, IncNSK2026-02-25
00810126380180Finish Denture - 4-7 TeethDigital Dental Laboratories, IncNSK2026-02-25
00810126380197Finish Denture - 8+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380203Flipper - 1 to 2 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380210Flipper - 3+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380227CastingDigital Dental Laboratories, IncNSK2026-02-25
00810126380234Set Denture - 1-3 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380241Set Denture - 4-7 teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380258Set Denture - 8+ teethDigital Dental Laboratories, IncNSK2026-02-25
00810126380265Unilateral Denture Teeth IncludedDigital Dental Laboratories, IncNSK2026-02-25
00810126380272Acetal unilateralDigital Dental Laboratories, IncNSK2026-02-25
00810126380289Framework acetalDigital Dental Laboratories, IncNSK2026-02-25
00810126380296Framework castDigital Dental Laboratories, IncNSK2026-02-25
00810126380302Unilateral castingDigital Dental Laboratories, IncNSK2026-02-25
00810126380319Unilateral dentureDigital Dental Laboratories, IncNSK2026-02-25
00810126380326Custom trayDigital Dental Laboratories, IncNSK2026-02-25
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
06977512700053DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
06977512700077DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDDTS Digital Dental LabNSO2024-06-13
J017A9C1000VITACOLLVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftNSK2023-04-17
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSP2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSK2023-02-20
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229994Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223329RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSP2022-10-20