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) | Registration & Listing | Adverse Events | Recalls | PMA | 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 K122501
Device Name AEI DR. TERAUCHI ULTRASONIC TIPS
Applicant
AMERICAN EAGLE INSTRUMENTS, INC.
6575 butler creek road
missoula,  MT  59808
Contact kristen schalliol
Regulation Number872.4850
Classification Product Code
ELC  
Date Received08/16/2012
Decision Date 03/29/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-