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510(k) K210228

Device
KLS Martin IPS Preprosthetic
Applicant
KLS-Martin L.P.
510(k) number
K210228
Product code
ELE  
Decision
Substantially Equivalent (SESE)
Decision date
2022-07-08
Date received
2021-01-28
Regulation
872.3645
Classification name
Implant, Subperiosteal
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jennifer Damato
Address
11201 Saint Johns Industrial Pkwy. S Jacksonville FL US 32246 32246

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code ELE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K862926SURGICAL VITEXJeneric Ind.1986-08-29
K843557K-APATITE 20-40 MESH K-APATITE 40-60Katecho, Inc.1984-11-30
K801208HOLLOW BASKET TITANIUM DENTAL IMPLANTColmed, Ltd.1980-05-28

Legacy Summary#

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FDA Review#

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