FDA.reportPublic FDA data

510(k) K251425

Device
turbodent touch
Applicant
Mectron S.P.A.
510(k) number
K251425
Product code
KOJ
Decision
Substantially Equivalent (SESE)
Decision date
2025-05-09
Date received
2025-05-08
Regulation
872.6080
Classification name
Airbrush
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
Yes

Applicant Contact#

Contact
Chiara Acunzo
Address
Via Loreto 15 Carasco IT 16042 16042

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KOJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K063236BETA-POWDERBrainbase Corporation2007-02-16
K042872RONDOFLEX PLUS 360Kavo America Corporation2004-11-23
K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbH2004-01-15
K033215PREPAIRDanville Materials, Inc.2004-01-09
K024105VELOPEX AQUACUT FLUID ABRASION UNITVelopex International, Inc.2003-10-09
K030292GROMAN PREPMASTERGroman, Inc.2003-04-15
K021450CLINPRO PROPHY POWDER3M Espe AG Dental Products2002-08-01
K014188NEW PROPHY POWDERDentsply Intl.2002-03-15
K014249JETPOLISHERDeldent , Ltd.2002-02-19
K014252JETSTREAMDeldent , Ltd.2002-02-19
K014245JETSONIC 2000Deldent , Ltd.2002-01-29
K013969MINIBLASTERDeldent , Ltd.2002-01-10
K984380DISPO ETCHKis Products2001-08-06
K993124DISPODRILLKis Products2001-08-06
K993182DISPOPROPHYKis Products2001-08-06