510(k) K880322

DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM by Dentronix, Inc. — Product Code KMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 1988
Date Received
January 27, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Sterilizer, Dry Heat
Device Class
Class II
Regulation Number
880.6870
Review Panel
HO
Submission Type