FDA.reportPublic FDA data

MOLEKUR

Primary DI
06975527187807
Brand
MOLEKUR
Company
Shanghai Coherz Technology Co., Ltd.
Model
Pro S Foil-0.76-150-F
Device description
1ROLL/PKG. It is used to make orthodontic aligners, retainers, mouth guards, etc.
Published
2026-04-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
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
06975527187807PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975527187807069755271878076975527187807

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
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06975527185100MOLEKUROne S+ Foil-0.76-802026-04-30
06975527186138MOLEKURExpress Foil-0.375-3002026-04-30
06975527187500MOLEKURPro S Disc-0.76-125-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
06975527182123Molekur ExpressExpress-Disc-0.63-1202022-09-05
06975527182130Molekur ExpressExpress-Disc-0.63-1202022-09-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
J01824971VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18
J01824972VECTOR® ScrewScheu-Dental GmbHDYJ2024-11-18