• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name scaler, ultrasonic
510(k) Number K122501
Device Name AEI DR. TERAUCHI ULTRASONIC TIPS
Original Applicant
AMERICAN EAGLE INSTRUMENTS, INC.
6575 butler creek road
missoula,  MT  59808
Original Contact kristen schalliol
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/16/2012
Decision Date 03/29/2013
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-