Molekur One

GUDID 06975527183038

10pcs/bag

Shanghai Coherz Technology Co., Ltd.

Dental appliance fabrication material, thermoplastic
Primary Device ID06975527183038
NIH Device Record Keyd7673679-dfd2-4d7f-af16-c0263be36909
Commercial Distribution StatusIn Commercial Distribution
Brand NameMolekur One
Version Model NumberOne-Disc-1.00-120
Company DUNS613781635
Company NameShanghai Coherz Technology Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS106975527183038 [Primary]

FDA Product Code

DYJRetainer, Screw Expansion, Orthodontic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-09-13
Device Publish Date2022-09-05

On-Brand Devices [Molekur One]

0697552718306910pcs/bag
0697552718305210pcs/bag
0697552718304510pcs/bag
0697552718303810pcs/bag
069755271830211roll/carton
069755271830141roll/carton

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.