FDA.reportPublic FDA data

510(k) K980672

Device
SIMPLEX AIRBRATOR (SAB-7)
Applicant
Irt Management Corp.
510(k) number
K980672
Product code
KOJ
Decision
Substantially Equivalent (SESE)
Decision date
2000-05-04
Date received
1998-02-20
Regulation
872.6080
Classification name
Airbrush
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
NICHOLAS G LEVANDOSKI, PH.D.
Address
470 Ansin Blvd., Suite G Hallandale FL US 33009 33009

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K042872RONDOFLEX PLUS 360Kavo America Corporation2004-11-23
K033675PROSMILE AIR POLISHER AND PROPHYLAXIS POWDERSirona Dental Systems GmbH2004-01-15
K033215PREPAIRDanville Materials, Inc.2004-01-09
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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