Cleared Traditional

K143445 - Tellos ISQ Buddy (FDA 510(k) Clearance)

Class I Dental device.

K143445 · Tellos Medical AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2016
Decision
401d
Days
Class 1
Risk

K143445 is an FDA 510(k) clearance for the Tellos ISQ Buddy. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Tellos Medical AB (Goteborg, SE). The FDA issued a Cleared decision on January 7, 2016 after a review of 401 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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.

View all Tellos Medical AB devices

Submission Details

510(k) Number K143445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2014
Decision Date January 07, 2016
Days to Decision 401 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
274d slower than avg
Panel avg: 127d · This submission: 401d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKX Handpiece, Direct Drive, Ac-powered
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EKX Handpiece, Direct Drive, Ac-powered

All 88
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K143445.
Alpha Endo Handpiece (Alpha Endo)
K252223 · SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. · Oct 2025
InnerView System
K251597 · Perimetrics, Inc. · Sep 2025
EnDrive (EnDriveUS)
K243692 · Advanced Technology Research (A.T.R.) S.R.L. · Aug 2025
Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)
K242514 · Shenzhen Rogin Medical Co., Ltd. · Apr 2025
ChecQ (AC100)
K241065 · Dentis Co., Ltd. · Mar 2025
HPR Cordless Hygiene Handpiece
K243911 · Handpiece Headquarters · Dec 2024