Cleared Traditional

Osstell Beacon (K181888) - FDA 510(k) Clearance

Class I Dental device.

K181888 · Osstell AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2019
Decision
405d
Days
Class 1
Risk

K181888 is an FDA 510(k) clearance for the Osstell Beacon. Classified as Handpiece, Direct Drive, Ac-powered (product code EKX), Class I - General Controls.

Submitted by Osstell AB (Gotenborg, SE). The FDA issued a Cleared decision on August 22, 2019 after a review of 405 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 Osstell AB devices

Submission Details

510(k) Number K181888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 13, 2018
Decision Date August 22, 2019
Days to Decision 405 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
278d slower than avg
Panel avg: 127d · This submission: 405d
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 Consultant

Msquared Associates, Inc.
Cherita James

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 - EKX Handpiece, Direct Drive, Ac-powered

All 88
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