Cleared Traditional

K201317 - TTBIO EVOCLEAN Ultrasonic Scaler

K201317 is an FDA 510(k) clearance for TTBIO EVOCLEAN Ultrasonic Scaler, manufactured by Ttbio Corp.. The device is a Class 2 Dental device with product code ELC cleared through the Traditional 510(k) pathway after a 200-day FDA review.

K201317 · Ttbio Corp. · Dental device
Download Printable Device Report (PDF)
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Dec 2020
Decision
200d
Days
Class 2
Risk

K201317 is an FDA 510(k) clearance for the TTBIO EVOCLEAN Ultrasonic Scaler. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Ttbio Corp. (Taichung, TW). The FDA issued a Cleared decision on December 4, 2020 after a review of 200 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ttbio Corp. devices

FDA 510(k) Submission Details - K201317

510(k) Number K201317 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2020
Decision Date December 04, 2020
Days to Decision 200 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
73d slower than avg
Panel avg: 127d · This submission: 200d
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 74
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K201317.
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