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 Scaler, Ultrasonic
510(k) Number K233922
Device Name SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
Applicant
Satelec - Acteon Group
17 Ave. Gustave Eiffel
Zi Du Phare
Merignac,  FR 33708
Applicant Contact Philippe Girard
Correspondent
Satelec - Acteon Group
124 Gaither Dr. Suite #140
Mt. Laurel,  NJ  08054
Correspondent Contact Noelle Zuccarello
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/13/2023
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
Predetermined Change
Control Plan Authorized		 No
-
-