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510(k) K100539

Device
PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDE
Applicant
PREVENTIVE TECHNOLOGIES, INC.
510(k) number
K100539
Product code
EJR  
Decision
Substantially Equivalent (SESE)
Decision date
2010-06-17
Date received
2010-02-25
Regulation
872.6030
Classification name
Agent, Polishing, Abrasive, Oral Cavity
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KENNETH S PETERSON
Address
4330 Mathews-Indian Trl. Rd. Indian Trial NC US 28079 28079

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJR  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K171189AIR-FLOW PLUS Prophylaxis powderE.M.S Electro Medical Systems S.A2017-09-11
K131760WHIP MIX PREPPIES PLUSWhip-Mix Corp.2014-03-26
K121698NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMINDentsply International, Inc.2012-08-06
K103114OSSPRAY SYLC CROsspray, Ltd.2011-03-14
K102053BUTLER CALCI-FLOR PROPHYLAXIS PASTESunstar Americas, Inc.2011-02-03
K101104REMIN PROVoco GmbH2010-10-21
K070854GC MI PASTE PLUSGC America, Inc.2007-04-12
K062502OSSPRAY CLEANING COMPOUNDOspray, Ltd.2006-12-15
K062166ENAMEL PROPremier Dental Products Co.2006-11-21
K042048GELATO PROPHYLAXIS PASTEDeepak Products, Inc.2004-10-26
K042200MI PASTEGC America, Inc.2004-10-20
K041371BUTLER NUCARE PROPHYLAXIS PASTE WITH NOVAMINNovamin Technology, Inc.2004-08-23
K040988ZIRCON-F PROPHYLAXIS PASTEPascal Co., Inc.2004-07-07
K033785PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDEDiscus Dental, Inc.2004-06-18
K040661RADENT PROPHY PASTEPascal Co., Inc.2004-06-09

Legacy Summary#

summary

FDA Review#

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