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FDA 510(k)

GBR System

K-Number: K233419 · 2025-01-03

ApplicantProimtech Saglik Urunleri Anonim Sirketi
Decision Date2025-01-03
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GBR System is the device name listed in this FDA 510(k) record. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. It received FDA 510(k) clearance on 2025-01-03 under 510(k) number K233419. 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 GBR System?

GBR System is a medical device that received FDA 510(k) clearance on 2025-01-03. The listed applicant is Proimtech Saglik Urunleri Anonim Sirketi. The 510(k) number is K233419.

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

GBR System received FDA 510(k) clearance on 2025-01-03, under 510(k) number K233419.

Who is the listed applicant for GBR System?

The FDA 510(k) record lists Proimtech Saglik Urunleri Anonim Sirketi as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GBR System?

The FDA product code for GBR System is DZL.

Other records listing Proimtech Saglik Urunleri Anonim Sirketi as applicant

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.

K231502Mini ScrewsK231100Proimtech Dental Body Implant, Proimtech Abutment, Proimtech Healing Cap, Proimtech Abutment Screw

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. KGK240321MP Pin flat without thread (36BMP000020/MP20)Hager& Meisinger GmbHK233721KLS Martin Drill-Free MMF ScrewKLS-Martin L.P.K231599Stryker MP, Mandible, HMMF and MMF AXS ScrewsStryker Leibinger GmbH & Co KG

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.

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