Cleared Traditional

K880940 - AMDENT MODEL 830 ULTRASONIC SCALER

K880940 is an FDA 510(k) clearance for AMDENT MODEL 830 ULTRASONIC SCALER, manufactured by Pathway Products, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 130-day FDA review.

K880940 · Pathway Products, Inc. · Dental device
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Jul 1988
Decision
130d
Days
Class 2
Risk

K880940 is an FDA 510(k) clearance for the AMDENT MODEL 830 ULTRASONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Pathway Products, Inc. (Austin, US). The FDA issued a Cleared decision on July 15, 1988 after a review of 130 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4850 - 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 Pathway Products, Inc. devices

FDA 510(k) Submission Details - K880940

510(k) Number K880940 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 07, 1988
Decision Date July 15, 1988
Days to Decision 130 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d slower than avg
Panel avg: 128d · This submission: 130d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELC Device Classification - Class 2, Special Controls

Product Code ELC Scaler, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4850
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 Dental devices follow this clearance model.

Regulatory Peers - ELC Scaler, Ultrasonic

All 142
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K880940.
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