FDA.reportPublic FDA data

DTS, RESTORATION, RESIN, CROWN AND

Primary DI
06977512700060
Brand
DTS, RESTORATION, RESIN, CROWN AND
Company
DTS Digital Dental Lab
Model
TEMPORARY CROWN AND
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
NSNRestoration, Resin, Crown And Bridge

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSNRestoration, Resin, Crown And BridgeUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977512700060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977512700060069775127000606977512700060

GMDN Terms#

Term, Definition table
TermDefinition
Dental bridge, polymerA custom-made, non-removable, artificial replacement for one or more missing teeth made entirely of polymer-based material, with or without fibre reinforcement, 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
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
D101SGI280Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSN2024-02-08
D101SGI240Stoneglass IndustriesSTONEGLASS DENTAL LABORATORY PTY LTDNSN2023-03-06
08936214229987Denture, Restoration Surgical guideACESO DENTAL LABORATORY COMPANY LIMITEDNSN2023-02-20
08936214223305Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223343Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223381RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224104Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224128Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224142Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214224166Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223398RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-20
08936214223145Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223169Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223183Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223206RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223220RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223244Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214223213RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-18
08936214221240Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-17
08936214221325Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-17
08936214221189Denture, Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-13
08936214221141Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221165Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221158Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214221172Restoration ACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-12
08936214220052RestorationACESO DENTAL LABORATORY COMPANY LIMITEDNSN2022-10-03
06975031820641CAD/CAM Fused Resin Crown PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820696CAD/CAM Fused Resin Pontic PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820740CAD/CAM Crown PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30
06975031820825CAD/CAM Pontic PEEKBeijing Yingguan Dental Technology Co., Ltd.NSN2022-09-30