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FDA 510(k)

SAVE GBR

K-Number: K222367 · 2023-03-23

ApplicantDentis Co., Ltd.
Decision Date2023-03-23
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SAVE GBR is the device name listed in this FDA 510(k) record. The listed applicant is Dentis Co., Ltd.. It received FDA 510(k) clearance on 2023-03-23 under 510(k) number K222367. The device is classified under product code DZL. 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 2023-03-23. The listed applicant is Dentis Co., Ltd.. The 510(k) number is K222367.

When did SAVE GBR receive FDA 510(k) clearance?

SAVE GBR received FDA 510(k) clearance on 2023-03-23, under 510(k) number K222367.

Who is the listed applicant for SAVE GBR?

The FDA 510(k) record lists Dentis Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SAVE GBR?

The FDA product code for SAVE GBR is DZL.

Other records listing Dentis Co., Ltd. as applicant

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Related Devices (Code: DZL)

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.

K250123Master-Pin X (MP Pin with thread) (36BMP000030 / MP30)Hager& Meisinger GmbHK251569Bone ScrewOsstem Implant Co., Ltd.K243190USTOMED Bone Fixation/Bone Augmentation Systems - PINUstomed Instrumente Ulrich Storz GmbH & Co. KGK233419GBR SystemProimtech Saglik Urunleri Anonim SirketiK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbHK233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.

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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