Cleared Traditional

K771557 - ULTRASON 990

K771557 is an FDA 510(k) clearance for ULTRASON 990, manufactured by Litton Dental Products. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K771557 · Litton Dental Products · Dental device
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Aug 1977
Decision
7d
Days
Class 2
Risk

K771557 is an FDA 510(k) clearance for the ULTRASON 990. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Litton Dental Products (Mchenry, US). The FDA issued a Cleared decision on August 19, 1977 after a review of 7 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 Litton Dental Products devices

FDA 510(k) Submission Details - K771557

510(k) Number K771557 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1977
Decision Date August 19, 1977
Days to Decision 7 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
121d faster than avg
Panel avg: 128d · This submission: 7d
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.