FDA 510(k)

SURGmatic S15 L Pro

K-Number: K213139 · 2021-12-21

Decision Date2021-12-21

Product CodeEGS

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

SURGmatic S15 L Pro is the device name listed in this FDA 510(k) record. The listed applicant is Kavo Dental GmbH. It received FDA 510(k) clearance on 2021-12-21 under 510(k) number K213139. The device is classified under product code EGS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SURGmatic S15 L Pro?

SURGmatic S15 L Pro is a medical device that received FDA 510(k) clearance on 2021-12-21. The listed applicant is Kavo Dental GmbH. The 510(k) number is K213139.

When did SURGmatic S15 L Pro receive FDA 510(k) clearance?

SURGmatic S15 L Pro received FDA 510(k) clearance on 2021-12-21, under 510(k) number K213139.

Who is the listed applicant for SURGmatic S15 L Pro?

The FDA 510(k) record lists Kavo Dental GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SURGmatic S15 L Pro?

The FDA product code for SURGmatic S15 L Pro is EGS.

Related Devices (Code: EGS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251869Disposable Prophy Angle (3399-60, 3399-090, 3399-105)Premium Plus (Dongguan) Limited K240950Disposable Prophy AnglePacific Care Limited K240183Star E900 Handpiece SeriesDentalez, Inc., Stardental Division K230106General Cutting StraightNakanishi, Inc.K222518FX ContraNakanishi, Inc.K220874Smooth Drive contra angle and straight handpiecesLares Research

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.