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 Resin, Root Canal Filling
510(k) Number K955703
Device Name NEO DENTAL ENDODONTIC IRRIGATION SYRINGE
Applicant
Neodental Chemical Products Co., Ltd.
7613 Carteret Rd.
Bethesda,  MD  20817
Applicant Contact KYLE H SIBINOVIC
Correspondent
Neodental Chemical Products Co., Ltd.
7613 Carteret Rd.
Bethesda,  MD  20817
Correspondent Contact KYLE H SIBINOVIC
Regulation Number872.3820
Classification Product Code
KIF  
Date Received12/14/1995
Decision Date 05/20/1996
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
-
-