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510(k) K953628

Device
PROPHY ANGLE
Applicant
ROLENCE ENTERPRISE CO. LTD.
510(k) number
K953628
Product code
EHK  
Decision
Substantially Equivalent (SESE)
Decision date
1995-09-29
Date received
1995-07-31
Regulation
872.6290
Classification name
Cup, Prophylaxis
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
STERLING CHENG
Address
226 Kong-Shieh-Sir Village Chungli, Taiwan TW

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code EHK  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K951016DISPOSABLE PROPHYLAXIS ANGLEPreventive Technologies, Inc.1995-05-02
K900507DISPOSABLE SCREW TYPE PROPHY BRUSHDentsply Intl.1990-04-10
K864059DENTAL PROPHY CUPS (VARIOUS TYPES)Mission White Dental, Inc.1986-11-19
K803155PROPHYLAXIS CUP.Teledyne Densco1981-01-08
K790723PROPHYLAXIS CUPS AND POLISHERSYoung Dental Manufacturing Co. 1, LLC1979-06-15
K780198PROPHY CUPS, R&RRansom and Randolph1978-02-16
K770556PRO-KUPDental Control Products1977-03-24

Legacy Summary#

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FDA Review#

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