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 Handpiece, Air-Powered, Dental
510(k) Number K141183
Device Name EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES
Applicant
Ttbio Corp.
2f, #7, 6th Rd. Industry Park
Taichung, Roc,  TW 40755
Applicant Contact SHU-CHING LEE
Correspondent
Ttbio Corp.
2f, #7, 6th Rd. Industry Park
Taichung, Roc,  TW 40755
Correspondent Contact SHU-CHING LEE
Regulation Number872.4200
Classification Product Code
EFB  
Date Received05/07/2014
Decision Date 02/27/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-