FDA.reportPublic FDA data

MOLEKUR

Primary DI
06975527188408
Brand
MOLEKUR
Company
Shanghai Coherz Technology Co., Ltd.
Model
Template U Foil-0.40-280
Device description
1 ROLL/PKG. It is used to make orthodontic aligners, orthodontic appliance retainers, mouth protectors etc.
Published
2026-06-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic
EBHMaterial, Impression Tray, Resin

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1
EBHMaterial, Impression Tray, ResinDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975527188408PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975527188408069755271884086975527188408

GMDN Terms#

Term, Definition table
TermDefinition
Dental appliance fabrication material, thermoplasticA thermoplastic material intended to be used in the dental laboratory to manufacture a patient-worn dental appliance (e.g., denture/denture base, orthodontic retainer, implant bars, crowns/bridges, occlusal splint, mouthguard); it might in addition be intended to fabricate non-patient worn devices (e.g., dental impression tray). The material [e.g., nylon 12 beads, polyetheretherketone (PEEK) milling blank, thermoplastic sheet] is manipulated [e.g., by melting and moulding, or computer-aided techniques (dental CAD/CAM)] to form the shape needed for the patient. After application, this material cannot be refabricated.

Regulatory Flags#

DUNS number
613781635
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975527188057MOLEKURTemplate U Disc-0.40-1252026-06-04
06975527185100MOLEKUROne S+ Foil-0.76-802026-04-30
06975527186138MOLEKURExpress Foil-0.375-3002026-04-30
06975527187500MOLEKURPro S Disc-0.76-125-F2026-04-30
06975527187807MOLEKURPro S Foil-0.76-150-F2026-04-30
06975527188149MOLEKURTemplate E Disc-0.50-1252026-04-17
06975527187784MOLEKURC8-F30-D00D-EN2025-04-30
06975527181027Molekur ProPro-Disc-0.76-1202022-09-05
06975527181034Molekur ProPro-Disc-0.76-1252022-09-05
06975527182017Molekur ExpressExpress-Foil-1.002022-09-05
06975527182024Molekur ExpressExpress-Foil-0.762022-09-05
06975527182031Molekur ExpressExpress-Foil-0.632022-09-05
06975527182048Molekur ExpressExpress-Disc-1.00-1202022-09-05
06975527182055Molekur ExpressExpress-Disc-1.00-1202022-09-05
06975527182062Molekur ExpressExpress-Disc-1.00-1252022-09-05
06975527182079Molekur ExpressExpress-Disc-1.00-1252022-09-05
06975527182086Molekur ExpressExpress-Disc-0.76-1202022-09-05
06975527182093Molekur ExpressExpress-Disc-0.76-1202022-09-05
06975527182109Molekur ExpressExpress-Disc-0.76-1252022-09-05
06975527182116Molekur ExpressExpress-Disc-0.76-1252022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.DYJ2026-06-04
06975527188057MOLEKURShanghai Coherz Technology Co., Ltd.EBH2026-06-04
08033707104513LEONE SPALEONE SPADYJ2026-05-28
10371347023326Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023333Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023340Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
10371347023357Advance Dental ProductsThe Atlanta Dental Supply CompanyDYJ2026-04-14
08033707104827LEONE SPALEONE SPADYJ2026-04-01
08033707104834LEONE SPALEONE SPADYJ2026-04-01
08800197901621ATOZ KeyMK Meditech Inc.DYJ2025-11-03
J011430120310prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
J011430120410prime4me®DENTAURUM GmbH & Co.KGDYJ2025-10-09
07895742296612MorelliDental Morelli LtdaDYJ2025-09-10
07895742296629MorelliDental Morelli LtdaDYJ2025-09-10
07895742296636MorelliDental Morelli LtdaDYJ2025-09-10
07895742296643MorelliDental Morelli LtdaDYJ2025-09-10
J011430120400prime4me®DENTAURUM GmbH & Co.KGDYJ2025-07-10
09359215000376DentaTRAY OrangeASIGA PTY LTDEBH2025-01-17
J01854551HerbstScheu-Dental GmbHDYJ2024-11-19
J01854561HerbstScheu-Dental GmbHDYJ2024-11-19
J01854571IST® Appliance / HerbstScheu-Dental GmbHDYJ2024-11-19
J01854581IST® ApplianceScheu-Dental GmbHDYJ2024-11-19
J01854661IST® ApplianceScheu-Dental GmbHDYJ2024-11-19
J01854681IST® ApplianceScheu-Dental GmbHDYJ2024-11-19
J01824921VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824922VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824941VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824942VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824961VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824962VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18