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FDA 510(k)

W&H Implantmed SI-1015 incl. Accessories

K-Number: K161957 · 2016-11-23

ApplicantW&H Dentalwerk Burmoos GmbH
Decision Date2016-11-23
Product CodeEBW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

W&H Implantmed SI-1015 incl. Accessories is the device name listed in this FDA 510(k) record. The listed applicant is W&H Dentalwerk Burmoos GmbH. It received FDA 510(k) clearance on 2016-11-23 under 510(k) number K161957. The device is classified under product code EBW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the W&H Implantmed SI-1015 incl. Accessories?

W&H Implantmed SI-1015 incl. Accessories is a medical device that received FDA 510(k) clearance on 2016-11-23. The listed applicant is W&H Dentalwerk Burmoos GmbH. The 510(k) number is K161957.

When did W&H Implantmed SI-1015 incl. Accessories receive FDA 510(k) clearance?

W&H Implantmed SI-1015 incl. Accessories received FDA 510(k) clearance on 2016-11-23, under 510(k) number K161957.

Who is the listed applicant for W&H Implantmed SI-1015 incl. Accessories?

The FDA 510(k) record lists W&H Dentalwerk Burmoos GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for W&H Implantmed SI-1015 incl. Accessories?

The FDA product code for W&H Implantmed SI-1015 incl. Accessories is EBW.

Other records listing W&H Dentalwerk Burmoos GmbH as applicant

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.

K162926Air-Powered Handpieces and Handpiece Attachments

Related Devices (Code: EBW)

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.

K251407Motor Handpiece and Control Unit (SDI10)Saeshin Precision Co., Ltd.K251701Star E900 Electric SystemDentalez, Inc., Stardental DivisionK251811Motor and Apex Module (MaAM)Dentsply Sirona, Inc.K231562ELEC ENGINE (Model: ISE-170L)Micro-Nx Co., Ltd.K242646Dental Implant UnitGuilin Aesthedent Medical Instruments Co., Ltd.K233288NLZ Built-In Motor SystemNakanishi, Inc.

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.

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