Cleared Traditional

K861601 - DP32 HAND HELD DENTAL PROPHYLAXIS UNIT

K861601 is an FDA 510(k) clearance for DP32 HAND HELD DENTAL PROPHYLAXIS UNIT, manufactured by Stewart J. Lustgarten. The device is a Class 1 Dental device with product code EIA cleared through the Traditional 510(k) pathway after a 171-day FDA review.

K861601 · Stewart J. Lustgarten · Dental device
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Oct 1986
Decision
171d
Days
Class 1
Risk

K861601 is an FDA 510(k) clearance for the DP32 HAND HELD DENTAL PROPHYLAXIS UNIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Stewart J. Lustgarten (Natick, US). The FDA issued a Cleared decision on October 17, 1986 after a review of 171 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory 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 Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Stewart J. Lustgarten devices

FDA 510(k) Submission Details - K861601

510(k) Number K861601 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1986
Decision Date October 17, 1986
Days to Decision 171 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 128d · This submission: 171d
Pathway characteristics
Predicate-based equivalence.

EIA Device Classification - Class 1, General Controls

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EIA Unit, Operative Dental

All 193
Devices cleared under the same product code (EIA) and FDA review panel - the closest regulatory comparables to K861601.
A-DEC DECADE CUSPIDOR
K903455 · A-Dec, Inc. · Oct 1990
SUCTION ORA-SWAB(R) BRUSH KIT
K901806 · Sage Products, Inc. · Aug 1990
DELIVERY PUMP FOR STERILE IRRIGANT & HANDPIECE DR.
K882526 · Aseptico, Inc. · Dec 1988
CM-II, CM-I WATER UNIT
K863021 · Sds Dental, Inc. · Oct 1986
EUROCART SR-4, EUROCART M-IV, ISOCART III
K863010 · Sds Dental, Inc. · Sep 1986
CABINET II AUXILIARY UNIT
K863023 · Sds Dental, Inc. · Sep 1986