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510(k) K992582

Device
PACIFIC IMPLANT TITANIUM ENDODONTIC POINT
Applicant
PACIFIC IMPLANT, INC.
510(k) number
K992582
Product code
EKL  
Decision
Substantially Equivalent (SESE)
Decision date
1999-10-21
Date received
1999-08-02
Regulation
872.3840
Classification name
Point, Silver, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DANIEL J MANELLI
Address
2000 M St., NW 7th Floor Washington DC US 20036 20036

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EKL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K961089PULPDENT ENDOPREP IIPulpdent Corp.1996-04-23
K822568EAR PROBESKelleher Corp.1982-09-14

Legacy Summary#

summary

FDA Review#

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