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FDA 510(k)

Sherlock

K-Number: K193335 · 2020-03-24

ApplicantOpen Implants, LLC
Decision Date2020-03-24
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Sherlock is the device name listed in this FDA 510(k) record. The listed applicant is Open Implants, LLC. It received FDA 510(k) clearance on 2020-03-24 under 510(k) number K193335. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Sherlock?

Sherlock is a medical device that received FDA 510(k) clearance on 2020-03-24. The listed applicant is Open Implants, LLC. The 510(k) number is K193335.

When did Sherlock receive FDA 510(k) clearance?

Sherlock received FDA 510(k) clearance on 2020-03-24, under 510(k) number K193335.

Who is the listed applicant for Sherlock?

The FDA 510(k) record lists Open Implants, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sherlock?

The FDA product code for Sherlock is NHA.

Other records listing Open Implants, LLC 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.

K250967SherlockK220482SherlockK212664Sherlock

Related Devices (Code: NHA)

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.

K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic ScrewNobel Biocare ABK261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A.K261122MIST ICImagine Milling Technologies, LLCK260061BioHorizons CEREC Compatible Ti-BasesBioHorizons Implant Systems, Inc.K253922Neodent Scannable Healing AbutmentJJGC Indústria e Comércio de Materiais Dentários S.A.K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC

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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