510(k) K051660

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM by Coltene/Whaledent, Inc. — Product Code KMH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 2005
Date Received
June 22, 2005
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