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 K033120
Device Name SCALETRON PIEZO ULTRASOUND SCALER
Applicant
Pac-Dent International (Suzhou), Ltd.
21078 Commerce Pt. Dr.
Walnut,  CA  91789
Applicant Contact DANIEL WANG
Correspondent
Pac-Dent International (Suzhou), Ltd.
21078 Commerce Pt. Dr.
Walnut,  CA  91789
Correspondent Contact DANIEL WANG
Regulation Number872.4850
Classification Product Code
ELC  
Date Received09/30/2003
Decision Date 01/29/2004
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
-
-