Cleared Traditional

K880322 - DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM
(FDA 510(k) Clearance)

K880322 · Dentronix, Inc. · General Hospital

Jul 1988

Decision

168d

Days

Class 2

Risk

K880322 is an FDA 510(k) clearance for the DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM, a Sterilizer, Dry Heat (Class II — Special Controls, product code KMH), submitted by Dentronix, Inc. (Ivyland, US). The FDA issued a Cleared decision on July 13, 1988, 168 days after receiving the submission on January 27, 1988. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6870.

Submission Details

510(k) Number	K880322 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 27, 1988
Decision Date	July 13, 1988
Days to Decision	168 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	—