Cleared Traditional

K834072 - INSTRUMENT, DENTAL

K834072 is an FDA 510(k) clearance for INSTRUMENT, manufactured by Venture Technology, Inc.. The device is a Class 1 Dental device with product code EMS cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K834072 · Venture Technology, Inc. · Dental device
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Feb 1984
Decision
88d
Days
Class 1
Risk

K834072 is an FDA 510(k) clearance for the INSTRUMENT, DENTAL. Classified as Curette, Periodontic (product code EMS), Class I - General Controls.

Submitted by Venture Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Venture Technology, Inc. devices

FDA 510(k) Submission Details - K834072

510(k) Number K834072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date February 21, 1984
Days to Decision 88 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 128d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

EMS Device Classification - Class 1, General Controls

Product Code EMS Curette, Periodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EMS Curette, Periodontic

Devices cleared under the same product code (EMS) and FDA review panel - the closest regulatory comparables to K834072.
CURRETTES, ALVEOLAR (MOLT AND MILLER)
K872091 · Military Engineering, Inc. · Jul 1987
CURETTE, PERIODONTAL, COLUMBIA UNIVERSITY
K870590 · Military Engineering, Inc. · Apr 1987
ELEVATOR - VARIOUS
K841011 · Premier Dental Products Co. · Jun 1984
DENTAL INSTRUMENTS - SCALERS
K823319 · Miltex, Inc. · Nov 1982
BEACH CURETTE NO. 2 AND NO. 3 T.G.
K821789 · Pacific Dental Corp. · Jul 1982