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FDA 510(k)

SAVE GBR

K-Number: K222451 · 2023-02-07

Decision Date2023-02-07
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAVE GBR is a medical device manufactured by Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-02-07 under approval number K222451. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAVE GBR?

SAVE GBR is a medical device that received FDA 510(k) clearance on 2023-02-07. It is manufactured by Dentis Co., Ltd.. The 510(k) number is K222451.

When was SAVE GBR approved by the FDA?

SAVE GBR received FDA 510(k) clearance on 2023-02-07, under approval number K222451.

What company makes SAVE GBR?

SAVE GBR is manufactured by Dentis Co., Ltd..

What is the FDA product code for SAVE GBR?

The FDA product code for SAVE GBR is NHA.

Other Devices by Dentis Co., Ltd.

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Related Devices (Code: NHA)

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.