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FDA 510(k)

EVO 700 series high speed handpiece

K-Number: K232243 · 2023-08-23

ApplicantTtbio Corp.
Decision Date2023-08-23
Product CodeEFB
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EVO 700 series high speed handpiece is a medical device manufactured by Ttbio Corp.. It received FDA 510(k) clearance on 2023-08-23 under approval number K232243. The device is classified under product code EFB. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EVO 700 series high speed handpiece?

EVO 700 series high speed handpiece is a medical device that received FDA 510(k) clearance on 2023-08-23. It is manufactured by Ttbio Corp.. The 510(k) number is K232243.

When was EVO 700 series high speed handpiece approved by the FDA?

EVO 700 series high speed handpiece received FDA 510(k) clearance on 2023-08-23, under approval number K232243.

What company makes EVO 700 series high speed handpiece?

EVO 700 series high speed handpiece is manufactured by Ttbio Corp..

What is the FDA product code for EVO 700 series high speed handpiece?

The FDA product code for EVO 700 series high speed handpiece is EFB.

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Other Devices by Ttbio Corp.

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Related Devices (Code: EFB)

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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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