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 Powder, Porcelain
510(k) Number K131117
Device Name ZIRMON SERIES
Applicant
Kuwotech Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Applicant Contact Priscilla Chung
Correspondent
Kuwotech Co., Ltd.
1515 E. Katella Ave.
Unit 2115
Anaheim,  CA  92805
Correspondent Contact Priscilla Chung
Regulation Number872.6660
Classification Product Code
EIH  
Date Received04/22/2013
Decision Date 07/26/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-