Cleared Traditional

K143445 - Tellos ISQ Buddy

K143445 is an FDA 510(k) clearance for Tellos ISQ Buddy, manufactured by Tellos Medical AB. The device is a Class 1 Dental device with product code EKX cleared through the Traditional 510(k) pathway after a 401-day FDA review.

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

FDA 510(k) Submission Details - K143445

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.

EKX Device Classification - Class 1, General Controls

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 57
Devices cleared under the same product code (EKX) and FDA review panel - the closest regulatory comparables to K143445.
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AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM
K142124 · Aseptico, Inc. · Dec 2014