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510(k) K980216

Device
KREATIV MACH 5, MACH 5 PLUS, MACH M, MACH 6
Applicant
KREATIV, INC.
510(k) number
K980216
Product code
KOJ  
Decision
Substantially Equivalent (SESE)
Decision date
1998-06-16
Date received
1998-01-21
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
JOE FOREHAND
Address
1517 Industrial Way, SW Albany OR US 97321 97321

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
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

Legacy Summary#

summary

FDA Review#

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