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FDA 510(k)

Surgical Drills

K-Number: K200265 · 2020-06-30

ApplicantImplant Direct Sybron Manufacturing, LLC
Decision Date2020-06-30
Product CodeDZI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Surgical Drills 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 2020-06-30 under 510(k) number K200265. 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 Surgical Drills?

Surgical Drills is a medical device that received FDA 510(k) clearance on 2020-06-30. The listed applicant is Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K200265.

When did Surgical Drills receive FDA 510(k) clearance?

Surgical Drills received FDA 510(k) clearance on 2020-06-30, under 510(k) number K200265.

Who is the listed applicant for Surgical Drills?

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 Surgical Drills?

The FDA product code for Surgical Drills 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.K231087Guided Surgery KitImplant Direct Sybron Manufacturing, LLC

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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