Cleared Traditional

EndoPilot2 (K202906) - FDA 510(k) Clearance

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

K202906 · Schlumbohm GmbH & Co. KG · Dental device
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Optimized for regulatory review, auditing and printing
Apr 2021
Decision
196d
Days
Class 2
Risk

K202906 is an FDA 510(k) clearance for the EndoPilot2. Classified as Scaler, Ultrasonic (product code ELC), Class II - Special Controls.

Submitted by Schlumbohm GmbH & Co. KG (Brokstedt, DE). The FDA issued a Cleared decision on April 13, 2021 after a review of 196 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 Schlumbohm GmbH & Co. KG devices

Submission Details

510(k) Number K202906 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2020
Decision Date April 13, 2021
Days to Decision 196 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
69d slower than avg
Panel avg: 127d · This submission: 196d
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.

Regulatory Consultant

Emergo Global Consulting, LLC
Oliver Eikenberg

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 35
Devices cleared under the same product code (ELC) and FDA review panel - the closest regulatory comparables to K202906.
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