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 Floss, Dental
510(k) Number K944034
Device Name PERIO-MED DENTAL FLOSS
Applicant
Whitehill Oral Technologies, Inc.
950 Highway 36
Hazlet,  NJ  07730
Applicant Contact IRA HILL
Correspondent
Whitehill Oral Technologies, Inc.
950 Highway 36
Hazlet,  NJ  07730
Correspondent Contact IRA HILL
Regulation Number872.6390
Classification Product Code
JES  
Date Received08/02/1994
Decision Date 07/25/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-