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 K113717
Device Name ULTRASONIC SCALER
Applicant
NAKANISHI, INC.
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Applicant Contact DIANE RUTHERFORD
Correspondent
NAKANISHI, INC.
1201 RICHARDSON DRIVE
SUITE 280
RICHARDSON,  TX  75080
Correspondent Contact DIANE RUTHERFORD
Regulation Number872.4850
Classification Product Code
ELC  
Date Received12/19/2011
Decision Date 03/05/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-