Cleared Traditional

K070866 - ASC-12 PIEZOELECTRIC SCALER

K070866 is an FDA 510(k) clearance for ASC-12 PIEZOELECTRIC SCALER, manufactured by Aseptico, Inc.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K070866 · Aseptico, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2007
Decision
13d
Days
Class 2
Risk

K070866 is an FDA 510(k) clearance for the ASC-12 PIEZOELECTRIC SCALER. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Aseptico, Inc. (Woodinville, US). The FDA issued a Cleared decision on April 11, 2007 after a review of 13 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 - K070866

510(k) Number K070866 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2007
Decision Date April 11, 2007
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 128d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
CASEY CONRY

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - ELC Scaler, Ultrasonic

All 175
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K070866.
SYMMETRY IQ, MODEL 2000 SERIES, 3000 SERIES
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K062731 · Nakanishi, Inc. · May 2007
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K053555 · Guilin Woodpecker Medical Instrument Co., Ltd. · Aug 2006
BONART ART-P3II & P4 PIEZO ELECTRIC ULTRASONIC SCALER UNITS WITH ACCESSORIES
K061448 · Bonart Co., Ltd. · Aug 2006
K070866 · ASC-12 PIEZOELECTRIC SCALER
Download PDF FDA Summary Aseptico, Inc.