Cleared Traditional

K922988 - ECO/DENTAL GENERAL DENTAL PACK

K922988 is an FDA 510(k) clearance for ECO/DENTAL GENERAL DENTAL PACK, manufactured by Dyna-Pace Systems, Inc.. The device is a Class 1 Dental device with product code EKJ cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K922988 · Dyna-Pace Systems, Inc. · Dental device
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Nov 1992
Decision
135d
Days
Class 1
Risk

K922988 is an FDA 510(k) clearance for the ECO/DENTAL GENERAL DENTAL PACK. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Dyna-Pace Systems, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 4, 1992 after a review of 135 days - within the typical 510(k) review window.

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: 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 Dyna-Pace Systems, Inc. devices

FDA 510(k) Submission Details - K922988

510(k) Number K922988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1992
Decision Date November 04, 1992
Days to Decision 135 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
8d slower than avg
Panel avg: 127d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

EKJ Device Classification - Class 1, General Controls

Product Code EKJ Burnisher, Operative
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 - EKJ Burnisher, Operative

All 23
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K922988.
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