FDA.reportPublic FDA data

510(k) K971692

Device
OSTEOPOWER SYSTEM AND ACCESSORIES
Applicant
OSTEOMED CORP.
510(k) number
K971692
Product code
KMW  
Decision
Substantially Equivalent (SESE)
Decision date
1997-06-27
Date received
1997-05-07
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
CINDY WALTERS
Address
3150 Premier Dr. #110 Irving TX US 75063 75063

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
K970953E-TYPE SPEED REDUCER CONTRA ANGLENsk Nakanishi, Inc.1997-04-15
K932255YOUNG D'GRANULATORYoung Dental Manufacturing Co. 1, LLC1994-04-15
K862110OSSEODENT DRILLING SYSTEMOtc/America1986-08-07

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases