FDA.reportPublic FDA data

DTS, RESTORATION, PORCELAIN-FUSED

Primary DI
06977512700084
Brand
DTS, RESTORATION, PORCELAIN-FUSED
Company
DTS Digital Dental Lab
Model
Porcelain Fused to
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
NSORestoration, Porcelain-Fused-To-Metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSORestoration, Porcelain-Fused-To-MetalUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977512700084PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977512700084069775127000846977512700084

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, metal-ceramicA custom-made, non-removable, artificial replacement for one or more missing teeth made of metal alloy combined with tooth-coloured ceramic material (veneer), and comprised of an artifical tooth/teeth and crowns. It is fixed to abutment/adjacent teeth, tooth roots, or dental implants. Also referred to as a fixed partial prosthesis or a fixed partial denture.

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
06977512700091DTS, DENTURES, FULLIMMEDIATE DENTURE2024-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214229994Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSO2023-02-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224005Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224029Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224043Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224081Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214225002Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-20
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223268Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214223282Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-18
08936214221288RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223008Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223046RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223060Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214223107RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221295RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-17
08936214221202Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-13
08936214221066RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221103Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221141Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214221073RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-12
08936214220014RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSO2022-10-03
06975031820054PFM Crown Ni-Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSO2022-09-30
06975031820061PFM Crown Co Cr (NP)Beijing Yingguan Dental Technology Co., Ltd.NSO2022-09-30