Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SURGmatic S15 L Pro

K-Number: K213139 · 2021-12-21

ApplicantKavo Dental GmbH
Decision Date2021-12-21
Product CodeEGS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SURGmatic S15 L Pro is a medical device manufactured by Kavo Dental GmbH. It received FDA 510(k) clearance on 2021-12-21 under approval 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. It is manufactured by Kavo Dental GmbH. The 510(k) number is K213139.

When was SURGmatic S15 L Pro approved by the FDA?

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

What company makes SURGmatic S15 L Pro?

SURGmatic S15 L Pro is manufactured by Kavo Dental GmbH.

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)

K162856Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE)Bonart Co., Ltd. K162397Titan 3 Low Speed Angle AttachmentsDentalez, Inc. K171436STRONG Dental HandpiecesSaeshin Precision Co., Ltd. K182892TRAUS Dental HandpiecesSaeshin Precision Co., Ltd. K182999General Cutting Contra HandpieceNakanishi, Inc. K181129STRONG Dental HandpiecesSaeshin Precision Co., Ltd.

Official Source

View on FDA Database →

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

↑