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510(k) K033675

Device
PROSMILE AIR POLISHER AND PROPHYLAXIS POWDER
Applicant
SIRONA DENTAL SYSTEMS GMBH
510(k) number
K033675
Product code
KOJ  
Decision
Substantially Equivalent (SESE)
Decision date
2004-01-15
Date received
2003-11-24
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
No

Applicant Contact#

Contact
MARY MCNAMARA-CULLINANE
Address
49 Plain St. North Attleboro MA US 02760 02760

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
K251425turbodent touchMectron S.P.A.2025-05-09
K063236BETA-POWDERBrainbase Corporation2007-02-16
K042872RONDOFLEX PLUS 360Kavo America Corporation2004-11-23
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

Legacy Summary#

summary

FDA Review#

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