FDA.reportPublic FDA data

ZenSplint

Primary DI
06972677870245
Brand
ZenSplint
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
024
Published
2026-04-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
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
06972677870245PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677870245069726778702456972677870245

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.

Regulatory Flags#

DUNS number
551746187
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06972677870214Trioclear System S,H2023-09-04
06972677870221Trioclear SystemS2023-09-04
06972677870238Trioclear SystemH2023-09-04
06972677871129Denture, splint1122020-07-21
06972677871143Anti-snoring, splint1142020-07-21
06972677871167Anti-snoring, splint1162020-07-21
06972677871242Restoration, splint1242020-07-21
06972677871341Restoration, splint1342020-07-21
06972677871402Restoration, splint1402020-07-21
06972677871525Denture, splint1522020-07-21
06972677871587Restoration, splint1582020-07-21
06972677871761Pink EF Series,Retainer1762022-08-26
06972677871785Blue Series,Splint1782022-08-26
06972677871808Pink Series,Splint1802022-08-26
06972677871846Pink EF Series,Splint1842022-08-26
06972677873147Restoration, orthodontic3142020-07-24
06972677873161Denture, splint3162020-07-24
06972677873222Anti-snoring, denture, splint3222020-07-24
06972677873246Anti-snoring, denture, splint3242020-07-24
06972677873284Denture, restoration, splint3282020-07-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06977512700039DTS, Prosthesis, orthodonticDTS Digital Dental LabNSR2024-06-13
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