FDA.report

510(k) K883418

Device
DE-BOND 200
Applicant
SCHEU-DENTAL
510(k) number
K883418
Product code
EKS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-24
Date received
1988-08-15
Regulation
872.4565
Classification name
File, Pulp Canal, Endodontic
Medical specialty
Dental
Review panel
Dental
Device class
1
Clearance type
Traditional
Third party reviewed
No
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
LOTHAR GRIESSBACH
Address
One Farragut Sq. S., NW Washington DC US 20006 20006

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF not indicated by FDA · openFDA JSON

Legacy Summary

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FDA Review

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