FDA.reportPublic FDA data

Restoration, orthodontic

Primary DI
06972677873499
Brand
Restoration, orthodontic
Company
Modern Dental Laboratory (DG) Co., Ltd.
Model
348
Published
2020-07-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
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
06972677873482PrimaryGS10
06972677873499Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06972677873482069726778734826972677873482
06972677873499069726778734996972677873499

GMDN Terms#

Term, Definition table
TermDefinition
Dental crown, polymerA device made entirely of polymer-based material with or without fibre reinforcement, and created for a specific patient, 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
3
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
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
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
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
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