FDA.reportPublic FDA data

DTS, DENTURES, PARTIAL

Primary DI
06977512700053
Brand
DTS, DENTURES, PARTIAL
Company
DTS Digital Dental Lab
Model
REMOVABLE PARTIAL
Published
2024-06-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
NSKDentures, Partial

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSKDentures, PartialUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977512700053PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977512700053069775127000536977512700053

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

Regulatory Flags#

DUNS number
617176585
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06977512700008DTS, RESTORATION, PORCELAINAll-ceramic Crown/Bridge2024-06-13
06977512700015DTS, RESTORATION, PORCELAINAll-ceramic Crown/Bridge2024-06-13
06977512700022DTS, RESTORATION, PORCELAINAll-ceramic Crown/Bridge2024-06-13
06977512700039DTS, Prosthesis, orthodonticRemovable Orthodontic2024-06-13
06977512700046DTS, DENTURES, FULLFULL DENTURE2024-06-13
06977512700060DTS, RESTORATION, RESIN, CROWN ANDTEMPORARY CROWN AND2024-06-13
06977512700077DTS, DENTURES, PARTIALDENTURES, PARTIAL2024-06-13
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDPorcelain Fused to 2024-06-13
06977512700091DTS, DENTURES, FULLIMMEDIATE DENTURE2024-06-13

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
06977512700077DTS, DENTURES, PARTIALDTS Digital Dental LabNSK2024-06-13
J017A9C1000VITACOLLVita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co KommanditgesellschaftNSK2023-04-17
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSK2023-02-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214224067Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214223350Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214224050Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-20
08936214223121Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-18
08936214223145Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSK2022-10-18