510(k) K982229

BI-DENT by Valley Forge Scientific Corp. — Product Code EKZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1998
Date Received
May 15, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Unit, Electrosurgical, And Accessories, Dental
Device Class
Class II
Regulation Number
872.4920
Review Panel
DE
Submission Type