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 Drill, Bone, Powered
510(k) Number K171326
Device Name Piezosurgery White
Applicant
Mectron S.P.A.
Via Loreto 15
Carasco,  IT 16042
Applicant Contact Franco Zunino
Correspondent
Backroads Consulting, Inc.
P.O. Box 566
Chesterland,  OH  44026
Correspondent Contact Karen E. Warden
Regulation Number872.4120
Classification Product Code
DZI  
Subsequent Product Code
ELC  
Date Received05/05/2017
Decision Date 04/13/2018
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
-
-