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510(k) K193405

Device
Simplant Digital Guide
Applicant
Dentsply Sirona
510(k) number
K193405
Product code
NDP  
Decision
Substantially Equivalent (SESE)
Decision date
2020-09-02
Date received
2019-12-09
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
Karl Nittinger
Address
221 W. Philadelphia St. Suite 60w York PA US 17401 17401

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
K190059CEREC GuidesDentsply Sirona2019-09-27
K170849SIMPLANT GuideDentsply Sirona2017-06-15
K070290SPI VECTODRILL CERAMIC DRILLSThommen Medical AG2007-04-17

Legacy Summary#

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FDA Review#

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