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 Crown And Bridge, Temporary, Resin
510(k) Number K151764
Device Name YAMAHACHI PMMA DISKS
Applicant
Yamahachi Dental Products USA, Inc.
160 Park Ave.
Nutley,  NJ  07110
Applicant Contact LAWRENCE G. GREENWALD
Correspondent
Denterprise International, Inc.
100 E Granada Blvd.
Suite 219
Ormond Beach,  FL  32176
Correspondent Contact JOHN F. GILLESPY
Regulation Number872.3770
Classification Product Code
EBG  
Date Received06/30/2015
Decision Date 11/23/2015
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
-
-