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510(k) K872251

Device
Abrasive Disc - Polishing Wheel
Applicant
DENTSPLY INTL.
510(k) number
K872251
Product code
EJR
Decision
Substantially Equivalent (SESE)
Decision date
1987-07-02
Date received
1987-06-12
Regulation
872.6030
Classification name
Agent, Polishing, Abrasive, Oral Cavity
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
JOHN O SEMMELMAN
Address
570 W. College Ave. P.O. Box 872 York PA US 17405 17405

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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K100539PREVENTECH PROPHYLAXIS PASTE WITH FLUORIDEPreventive Technologies, Inc.2010-06-17
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