Cleared Traditional

K070975 - SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES

K070975 is an FDA 510(k) clearance for SYMMETRY IQ, manufactured by Hu-Friedy Mfg. Co., Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K070975 · Hu-Friedy Mfg. Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
76d
Days
Class 2
Risk

K070975 is an FDA 510(k) clearance for the SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Hu-Friedy Mfg. Co., Inc. (Chicago, US). The FDA issued a Cleared decision on June 21, 2007 after a review of 76 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 Hu-Friedy Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K070975

510(k) Number K070975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date June 21, 2007
Days to Decision 76 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 127d · This submission: 76d
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 84
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K070975.
SONICFLEX 2003 AND SONICFLEX LUX 2003 L WITH INSTRUMENT TIPS
K080089 · Sybron Dental Specialties, Inc. · Sep 2008
VARIOS 75
K071447 · Nakanishi, Inc. · Apr 2008
PERIOSCAN, MODEL: D 3496
K072107 · Sirona Dental Systems GmbH · Feb 2008
STERI -MATE HANDPIECE SLEEVE WITH LED LIGHT
K070307 · Dentsply International, Inc. · May 2007
ULTRASONIC SCALER, VARIOS 560
K062731 · Nakanishi, Inc. · May 2007
ASC-12 PIEZOELECTRIC SCALER
K070866 · Aseptico, Inc. · Apr 2007