FDA.reportPublic FDA data

splint

Primary DI
06972677870078
Brand
splint
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
007
Published
2020-07-21
Public version status
Update
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
06972677870078PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677870078069726778700786972677870078

GMDN Terms#

Term, Definition table
TermDefinition
Orthodontic retainerA dental orthodontic appliance, fixed or removable, used to maintain teeth in corrected positions during the period of functional adaptation following corrective treatment. This appliance is also used to maintain the positions of the teeth and jaws gained by orthodontic procedures. This is a single-patient device that is used for the duration of the treatment (single-use) before being discarded.

Sterilization Methods#

Method table
Method

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
06972677870245ZenSplint0242026-04-28
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06972677870245ZenSplintModern Dental Laboratory (DG) Co., Ltd.NSR2026-04-28
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