Cleared Traditional

SURGmatic S15 L Pro (K213139) - FDA 510(k) Clearance

Class I Dental device.

K213139 · Kavo Dental GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2021
Decision
85d
Days
Class 1
Risk

K213139 is an FDA 510(k) clearance for the SURGmatic S15 L Pro. Classified as Handpiece, Contra- And Right-angle Attachment, Dental (product code EGS), Class I - General Controls.

Submitted by Kavo Dental GmbH (Biberach, DE). The FDA issued a Cleared decision on December 21, 2021 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kavo Dental GmbH devices

Submission Details

510(k) Number K213139 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2021
Decision Date December 21, 2021
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EGS Handpiece, Contra- And Right-angle Attachment, Dental
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 - EGS Handpiece, Contra- And Right-angle Attachment, Dental

All 13
Devices cleared under the same product code (EGS) and FDA review panel - the closest regulatory comparables to K213139.
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TRAUS Dental Handpieces
K182892 · Saeshin Precision Co., Ltd. · Nov 2019
General Cutting Contra Handpiece
K182999 · Nakanishi, Inc. · Apr 2019