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510(k) K070290

Device
SPI VECTODRILL CERAMIC DRILLS
Applicant
THOMMEN MEDICAL, AG
510(k) number
K070290
Product code
NDP  
Decision
Substantially Equivalent (SESE)
Decision date
2007-04-17
Date received
2007-01-30
Regulation
872.3980
Classification name
Accessories, Implant, Dental, Endosseous
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Floyd Larson
Address
11234 El Camino Real Suite 200 San Diego CA US 92130 92130

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NDP  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K193405Simplant Digital GuideDentsply Sirona2020-09-02
K190059CEREC GuidesDentsply Sirona2019-09-27
K170849SIMPLANT GuideDentsply Sirona2017-06-15

Legacy Summary#

summary

FDA Review#

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