FDA 510(k) Application Details - K233921

Device Classification Name Chair, Dental, With Operative Unit

  More FDA Info for this Device
510(K) Number K233921
Device Name Chair, Dental, With Operative Unit
Applicant DENTIS CO., LTD.
99, Seongseoseo-Ro, Dalseo-Gu
Daegu 42718 KR
Other 510(k) Applications for this Company
Contact Kim Kaon
Other 510(k) Applications for this Contact
Regulation Number 872.6250

  More FDA Info for this Regulation Number
Classification Product Code KLC
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 12/13/2023
Decision Date 09/06/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee DE - Dental
Review Advisory Committee DE - Dental
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review

FDA Source Information for K233921


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact