Cleared Traditional

K880322 - DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM

K880322 is an FDA 510(k) clearance for DENTRONIX DDS 5000 DRY HEAT STERILIZATI..., manufactured by Dentronix, Inc.. The device is a Class 2 General Hospital device with product code KMH cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K880322 · Dentronix, Inc. · General Hospital
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Jul 1988
Decision
168d
Days
Class 2
Risk

K880322 is an FDA 510(k) clearance for the DENTRONIX DDS 5000 DRY HEAT STERILIZATION SYSTEM. Classified as Sterilizer, Dry Heat (product code KMH), Class II - Special Controls.

Submitted by Dentronix, Inc. (Ivyland, US). The FDA issued a Cleared decision on July 13, 1988 after a review of 168 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6870 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentronix, Inc. devices

FDA 510(k) Submission Details - K880322

510(k) Number K880322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 129d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KMH Device Classification - Class 2, Special Controls

Product Code KMH Sterilizer, Dry Heat
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6870
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.