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 K950365
Device Name MOYCO-EDTA
Applicant
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
DIVISION OF MOYCO IND., INC.
P.O. BOX 508, ABERDEEN ROAD
EMIGSVILLE,  PA  17318
Applicant Contact CHRIS M LEHR
Correspondent
UNION BROACH, DIV. MOYCO INDUSTRIES, INC.
DIVISION OF MOYCO IND., INC.
P.O. BOX 508, ABERDEEN ROAD
EMIGSVILLE,  PA  17318
Correspondent Contact CHRIS M LEHR
Classification Product Code
KJJ  
Date Received01/31/1995
Decision Date 04/27/1995
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-