FDA.report

510(k) K120861

Device
FIN-S MICROIMPLANT
Applicant
CREEKSIDE ORTHODONTICS
510(k) number
K120861
Product code
OAT  
Decision
Substantially Equivalent (SESE)
Decision date
2013-02-21
Date received
2012-03-22
Regulation
872.3640
Classification name
Implant, Endosseous, Orthodontic
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
JOHN T KALANGE
Address
136 E. Mallard Dr. Boise ID US 83706 83706

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Legacy Summary

summary

FDA Review

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