Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name controller, foot, handpiece and cord
510(k) Number K231864
Device Name Fiber Optic Brushless Electronic Micromotor, model: iM100
Applicant
Codent Technical Industry Co., Ltd.
2F., No.100, Luke 5th Rd., Luzhu Dist.
Kaohsiung City,  TW 821
Applicant Contact Jyun-Ming Shuo
Correspondent
Codent Technical Industry Co., Ltd.
2F., No.100, Luke 5th Rd., Luzhu Dist.
Kaohsiung City,  TW 821
Correspondent Contact Jyun-Ming Shuo
Regulation Number872.4200
Classification Product Code
EBW  
Date Received06/26/2023
Decision Date 03/11/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-