FDA 510(k)

OK Handpiece

K-Number: K221814 · 2022-07-15

Decision Date2022-07-15

Product CodeEFB

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OK Handpiece is a medical device manufactured by Jaintek Co.,Ltd. It received FDA 510(k) clearance on 2022-07-15 under approval number K221814. 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 OK Handpiece?

OK Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. It is manufactured by Jaintek Co.,Ltd. The 510(k) number is K221814.

When was OK Handpiece approved by the FDA?

OK Handpiece received FDA 510(k) clearance on 2022-07-15, under approval number K221814.

What company makes OK Handpiece?

OK Handpiece is manufactured by Jaintek Co.,Ltd.

What is the FDA product code for OK Handpiece?

The FDA product code for OK Handpiece is EFB.

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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.