FDA.reportPublic FDA data

DTS, DENTURES, FULL

Primary DI
06977512700091
Brand
DTS, DENTURES, FULL
Company
DTS Digital Dental Lab
Model
IMMEDIATE DENTURE
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
NSLDentures, Full

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSLDentures, FullUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977512700091PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977512700091069775127000916977512700091

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

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
06977512700053DTS, DENTURES, PARTIALREMOVABLE PARTIAL 2024-06-13
06977512700060DTS, RESTORATION, RESIN, CROWN ANDTEMPORARY CROWN AND2024-06-13
06977512700077DTS, DENTURES, PARTIALDENTURES, PARTIAL2024-06-13
06977512700084DTS, RESTORATION, PORCELAIN-FUSEDPorcelain Fused to 2024-06-13

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
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
08936214223190Denture, 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