FDA.reportPublic FDA data

DTS, Prosthesis, orthodontic

Primary DI
06977512700039
Brand
DTS, Prosthesis, orthodontic
Company
DTS Digital Dental Lab
Model
Removable Orthodontic
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
NSRProsthesis, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NSRProsthesis, OrthodonticUnknownN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06977512700039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06977512700039069775127000396977512700039

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerAn orthodontic appliance, bonded or removable, intended to be used on a single patient to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance, also referred to as a positioner, is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures.

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
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
06977512700091DTS, DENTURES, FULLIMMEDIATE DENTURE2024-06-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972677870245ZenSplintModern Dental Laboratory (DG) Co., Ltd.NSR2026-04-28
06972677871761Pink EF Series,RetainerModern Dental Laboratory (DG) Co., Ltd.NSR2022-08-26
06972677871785Blue Series,SplintModern Dental Laboratory (DG) Co., Ltd.NSR2022-08-26
06972677871808Pink Series,SplintModern Dental Laboratory (DG) Co., Ltd.NSR2022-08-26
06972677871822Blue EF Series,SplintModern Dental Laboratory (DG) Co., Ltd.NSR2022-08-26
06972677871846Pink EF Series,SplintModern Dental Laboratory (DG) Co., Ltd.NSR2022-08-26
06972677879989Denture,restoration,orthodontic,anti-snoring,orthodonticModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-30
06972677873147Restoration, orthodonticModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873161Denture, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873222Anti-snoring, denture, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873246Anti-snoring, denture, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873284Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873307Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873345Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873406Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873444Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873482Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677873543Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-24
06972677874069Denture, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677874106Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677874120Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677874182Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677875028Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677875042Denture, restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-22
06972677871129Denture, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21
06972677871143Anti-snoring, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21
06972677871167Anti-snoring, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21
06972677871242Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21
06972677871341Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21
06972677871402Restoration, splintModern Dental Laboratory (DG) Co., Ltd.NSR2020-07-21