Cleared Traditional

K182145 - tün® ultrasonic tips product family (FDA 510(k) Clearance)

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K182145 · Engineered Endodontics · Dental device
Jun 2019
Decision
303d
Days
Class 2
Risk

K182145 is an FDA 510(k) clearance for the tün® ultrasonic tips product family. This device is classified as a Scaler, Ultrasonic (Class II - Special Controls, product code ELC).

Submitted by Engineered Endodontics (Menomonee Falls, US). The FDA issued a Cleared decision on June 7, 2019, 303 days after receiving the submission on August 8, 2018.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4850.

Submission Details

510(k) Number K182145 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2018
Decision Date June 07, 2019
Days to Decision 303 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
145d slower than avg
Panel avg: 158d · This submission: 303d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.