Cleared Traditional

K113530 - ULTRASONIC SCALER

K113530 is an FDA 510(k) clearance for ULTRASONIC SCALER, manufactured by Nakanishi, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 428-day FDA review.

K113530 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF)
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Jan 2013
Decision
428d
Days
Class 2
Risk

K113530 is an FDA 510(k) clearance for the ULTRASONIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Nakanishi, Inc. (Richardson, US). The FDA issued a Cleared decision on January 31, 2013 after a review of 428 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Nakanishi, Inc. devices

FDA 510(k) Submission Details - K113530

510(k) Number K113530 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2011
Decision Date January 31, 2013
Days to Decision 428 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
301d slower than avg
Panel avg: 127d · This submission: 428d
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 83
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