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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 a medical device manufactured by Implant Direct Sybron Manufacturing, LLC. It received FDA 510(k) clearance on 2023-08-16 under approval 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. It is manufactured by Implant Direct Sybron Manufacturing, LLC. The 510(k) number is K231087.

When was Guided Surgery Kit approved by the FDA?

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

What company makes Guided Surgery Kit?

Guided Surgery Kit is manufactured by Implant Direct Sybron Manufacturing, LLC.

What is the FDA product code for Guided Surgery Kit?

The FDA product code for Guided Surgery Kit is DZI.

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Other Devices by Implant Direct Sybron Manufacturing, LLC

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Related Devices (Code: DZI)

K152125Oral Surgery System and AccessoriesBonart Co., Ltd. K172137PIEZOTOME CUBESatelec - Acteon Group K171326Piezosurgery WhiteMectron S.P.A. K171958PIEZOSURGERY TOUCH, PIEZOSURGERY WHITEMectron S.P.A. K192561TRAUS SUS20Saeshin Precision Co., Ltd. K200265Surgical DrillsImplant 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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