FDA.reportPublic FDA data

Denture, Restoration

Primary DI
08936214223121
Brand
Denture, Restoration
Company
ACESO DENTAL LABORATORY COMPANY LIMITED
Model
312
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
NSJRestoration, Noble Metal
NSKDentures, Partial
NSLDentures, Full

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSJRestoration, Noble MetalUnknownN
NSKDentures, PartialUnknownN
NSLDentures, FullUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08936214223121PrimaryGS10
08936214223138Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08936214223121089362142231218936214223121
08936214223138089362142231388936214223138

GMDN Terms#

Term, Definition table
TermDefinition
Dental casting noble alloyA material composed primarily of noble metals [e.g., gold (Au), palladium (Pd), platinum (Pt), or silver (Ag)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.

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
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
06977512700046DTS, DENTURES, FULLDTS Digital Dental LabNSL2024-06-13
06977512700053DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
06977512700077DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
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
J017A9C1000VITACOLLVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftNSK2023-04-17
D101SGI170Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSL2023-04-05
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSK2023-02-20