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510(k) K801208

Device
HOLLOW BASKET TITANIUM DENTAL IMPLANT
Applicant
COLMED, LTD.
510(k) number
K801208
Product code
ELE  
Decision
Substantially Equivalent (SESE)
Decision date
1980-05-28
Date received
1980-05-20
Regulation
872.3645
Classification name
Implant, Subperiosteal
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
4221 Richmond Rd., NW Walker MI US 49534 49534

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code ELE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K210228KLS Martin IPS PreprostheticKLS-Martin L.P.2022-07-08
K862926SURGICAL VITEXJeneric Ind.1986-08-29
K843557K-APATITE 20-40 MESH K-APATITE 40-60Katecho, Inc.1984-11-30

Legacy Summary#

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FDA Review#

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