Cleared Traditional

DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM

K051660 · Coltene/Whaledent, Inc. · General Hospital
Aug 2005
Decision
43d
Days
Class 2
Risk

About This 510(k) Submission

K051660 is an FDA 510(k) clearance for the DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM, a Sterilizer, Dry Heat (Class II — Special Controls, product code KMH), submitted by Coltene/Whaledent, Inc. (Cuyahoga Falls, US). The FDA issued a Cleared decision on August 4, 2005, 43 days after receiving the submission on June 22, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number K051660 FDA.gov
FDA Decision Cleared SESE
Date Received June 22, 2005
Decision Date August 04, 2005
Days to Decision 43 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code KMH — Sterilizer, Dry Heat
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6870

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