Cleared Traditional

K901488 - LYNX-SM, SCLAER DENTAL HANDPIECE

K901488 is an FDA 510(k) clearance for LYNX-SM, manufactured by Mti Precision Products. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K901488 · Mti Precision Products · Dental device
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May 1990
Decision
47d
Days
Class 2
Risk

K901488 is an FDA 510(k) clearance for the LYNX-SM, SCLAER DENTAL HANDPIECE. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Mti Precision Products (Lakewood, US). The FDA issued a Cleared decision on May 15, 1990 after a review of 47 days - a notably fast clearance cycle.

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: 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 Mti Precision Products devices

FDA 510(k) Submission Details - K901488

510(k) Number K901488 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1990
Decision Date May 15, 1990
Days to Decision 47 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 127d · This submission: 47d
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 97
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K901488.
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