GUDID 06974803440001

Shenzhen Yinuo Dental Technology Co.LTD

Orthodontic progressive aligner
Primary Device ID06974803440001
NIH Device Record Keyf556b4ab-ceef-41cf-8130-ec8fb81746fe
Commercial Distribution StatusIn Commercial Distribution
Version Model NumberV1.0
Company DUNS412473497
Company NameShenzhen Yinuo Dental Technology Co.LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
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 Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106974803440001 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NXCAligner, Sequential

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-11-08
Device Publish Date2021-10-29

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.