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, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
510(k) Number K243280
Device Name Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
Applicant
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Straße 53
Buermoos,  AT 5111
Applicant Contact Gerhard Weidler
Correspondent
W&H Dentalwerk Buermoos GmbH
Ignaz-Glaser-Straße 53
Buermoos,  AT 5111
Correspondent Contact Gerhard Weidler
Regulation Number874.4250
Classification Product Code
ERL  
Subsequent Product Codes
DZI   HWE   JDX  
Date Received10/17/2024
Decision Date 07/03/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel Ear Nose & Throat
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-