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, Denture, Relining, Repairing, Rebasing
510(k) Number K152051
Device Name ClearMet
Applicant
Mycone Dental Supply Co., T/A Keystone Industries
T/A Keystone Industries, Mizzy & Deepak Products
52 W. King St.
Myerstown,  PA  17067
Applicant Contact Tracey Schwear
Correspondent
Mycone Dental Supply Co., T/A Keystone Industries
T/A Keystone Industries, Mizzy & Deepak Products
52 W. King St.
Myerstown,  PA  17067
Correspondent Contact Tracey Schwear
Regulation Number872.3760
Classification Product Code
EBI  
Date Received07/23/2015
Decision Date 03/22/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-