FDA.reportPublic FDA data

Restoration, splint

Primary DI
06972677871587
Brand
Restoration, splint
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
158
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
NSNRestoration, Resin, Crown And Bridge
NSRProsthesis, Orthodontic

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06972677871587PrimaryGS10
06972677871594Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677871587069726778715876972677871587
06972677871594069726778715946972677871594

GMDN Terms#

Term, Definition table
TermDefinition
Custom-made dental crown, metal/polymerA device made of metal, veneered with a polymer-based, tooth-coloured material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
551746187
Device count
2
DM exempt
true
Premarket exempt
true
Lot or batch
true
Sterilization required before use
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
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
06972677870245ZenSplintModern Dental Laboratory (DG) Co., Ltd.NSR2026-04-28
06977512700039DTS, Prosthesis, orthodonticDTS Digital Dental LabNSR2024-06-13
06977512700060DTS, RESTORATION, RESIN, CROWN ANDDTS Digital Dental LabNSN2024-06-13
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