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FDA 510(k)

Guided Surgery Kit

K-Number: K231087 · 2023-08-16

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2023-08-16
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Guided Surgery Kit is the device name listed in this FDA 510(k) record. The listed applicant is Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-08-16 under 510(k) number K231087. The device is classified under product code DZI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Guided Surgery Kit?

Guided Surgery Kit is a medical device that received FDA 510(k) clearance on 2023-08-16. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K231087.

When did Guided Surgery Kit receive FDA 510(k) clearance?

Guided Surgery Kit received FDA 510(k) clearance on 2023-08-16, under 510(k) number K231087.

Who is the listed applicant for Guided Surgery Kit?

The FDA 510(k) record lists Implant Direct Sybron Manufacturing, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Guided Surgery Kit?

The FDA product code for Guided Surgery Kit is DZI.

Other records listing Implant Direct Sybron Manufacturing, LLC as applicant

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Related Devices (Code: DZI)

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.

K253655Angled Screwdriver MED (M-SD090)W&H Dentalwerk Bürmoos GmbHK253776Implantmed Plus II & Piezomed Plus II ModuleW&H Dentalwerk Buermoos GmbHK254163VarioSurg 4Nakanishi, Inc.K242432MT-BoneMectron S.P.A.K240340Surgical Drive System (Model: ES70, ES90, E8)Guangdong Jinme Medical Technology Co., Ltd.K192561TRAUS SUS20Saeshin 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.

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