FDA.reportPublic FDA data

Molekur Express

Primary DI
06975527182017
Brand
Molekur Express
Company
Shanghai Coherz Technology Co., Ltd.
Model
Express-Foil-1.00
Device description
1 roll/box
Published
2022-09-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
DYJRetainer, Screw Expansion, Orthodontic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DYJRetainer, Screw Expansion, OrthodonticDental1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06975527182017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06975527182017069755271820176975527182017

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
613781635
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
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
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
00840456221761JMUJMU DENTAL, INCDYJ2026-05-11
00840456221778JMUJMU DENTAL, INCDYJ2026-05-11
D775AHAD0Hawley Retainer with Adams ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHAR0Hawley Retainer with Arrow ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHBC0Hawley Retainer with Ball ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775AHCC0Hawley Retainer with Circumferential ClaspsGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEL0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMARPEP0MARPEGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
D775BMMT0MemotainGreat Lakes Dental Technologies, Ltd.DYJ2026-05-10
00197998216633Clarity™Solventum Orthodontics CorporationDYJ2026-04-25
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
D775AEA0Expansion ApplianceGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775AH0Hawley RetainerGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
D775BKS0Keles SliderGreat Lakes Dental Technologies, Ltd.DYJ2026-04-13
00190746202766PowerScopeAMERICAN ORTHODONTICS CORPORATIONDYJ2026-04-08
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
J01854551HerbstScheu-Dental GmbHDYJ2024-11-19