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510(k) K932255

Device
YOUNG D'GRANULATOR
Applicant
YOUNG DENTAL MANUFACTURING CO 1, LLC.
510(k) number
K932255
Product code
KMW  
Decision
Substantially Equivalent (SESE)
Decision date
1994-04-15
Date received
1993-05-10
Regulation
872.4120
Classification name
Handpiece, Rotary Bone Cutting
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JEFF KOPP
Address
13705 Shoreline Ct. E. Earth City MO US 63045 63045

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code KMW  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K211584Oral Surgery ContraNakanishi, Inc.2021-08-19
K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc.2017-11-21
K162544OsteoMed PINNACLE DriverOsteomed2017-04-04
K080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESW&H Dentalwerk Buermoos GmbH2008-07-29
K994298FRIOS MICROSAWFriadent GmbH2000-02-18
K971692OSTEOPOWER SYSTEM AND ACCESSORIESOsteomed Corp.1997-06-27
K970953E-TYPE SPEED REDUCER CONTRA ANGLENsk Nakanishi, Inc.1997-04-15
K862110OSSEODENT DRILLING SYSTEMOtc/America1986-08-07

Legacy Summary#

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FDA Review#

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