Cleared Traditional

K113717 - ULTRASONIC SCALER

K113717 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 442-day FDA review.

K113717 · Nakanishi, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
442d
Days
Class 2
Risk

K113717 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 March 5, 2013 after a review of 442 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.

FDA 510(k) Submission Details - K113717

510(k) Number K113717 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 19, 2011
Decision Date March 05, 2013
Days to Decision 442 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
314d slower than avg
Panel avg: 128d · This submission: 442d
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 163
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K113717.
SONENDO ENDOTHERAPY SYSTEM
K130025 · Sonendo, Inc. · Jun 2013
AEI DR. TERAUCHI ULTRASONIC TIPS
K122501 · American Eagle Instruments, Inc. · Mar 2013
ADVANCED ENDODONTIC SYSTEM- DESIGNER SERIES
K123139 · Asi Medical, Inc. · Mar 2013
ULTRASONIC SCALER
K113530 · Nakanishi, Inc. · Jan 2013
PROULTRA PIEZO ULTRASONIC
K113430 · Satelec - Acteon Group · Feb 2012
EMS AIR-FLOW MASTER PIEZON
K110173 · E.M.S Electro Medical Systems S.A · Apr 2011
K113717 · ULTRASONIC SCALER
Download PDF FDA Summary Nakanishi, Inc.