Cleared Traditional

K062791 - USI DENTAL SCALER, 25XXX SERIES

K062791 is an FDA 510(k) clearance for USI DENTAL SCALER, manufactured by Ultrasonic Services, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K062791 · Ultrasonic Services, Inc. · Dental device
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Dec 2006
Decision
84d
Days
Class 2
Risk

K062791 is an FDA 510(k) clearance for the USI DENTAL SCALER, 25XXX SERIES. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Ultrasonic Services, Inc. (Houston, US). The FDA issued a Cleared decision on December 11, 2006 after a review of 84 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.

FDA 510(k) Submission Details - K062791

510(k) Number K062791 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2006
Decision Date December 11, 2006
Days to Decision 84 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · This submission: 84d
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 175
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K062791 · USI DENTAL SCALER, 25XXX SERIES
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