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 Cleanser, Root Canal
510(k) Number K003422
Device Name EDTA ROOT CANAL CLEANSER
Applicant
Super Glide, Inc.
227 Colchester Ave.
Burlington,  VT  05401
Applicant Contact VICTOR L RATKUS
Correspondent
Super Glide, Inc.
227 Colchester Ave.
Burlington,  VT  05401
Correspondent Contact VICTOR L RATKUS
Classification Product Code
KJJ  
Date Received11/03/2000
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-