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FDA 510(k)

Guided Bone Regeneration System

K-Number: K254286 · 2026-08-24

ApplicantDentalMaster(Xiamen)Medical Technology Co., Ltd.
Decision Date2026-08-24
Product CodeDZL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Guided Bone Regeneration System is the device name listed in this FDA 510(k) record. The listed applicant is DentalMaster(Xiamen)Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-24 under 510(k) number K254286. 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 Guided Bone Regeneration System?

Guided Bone Regeneration System is a medical device that received FDA 510(k) clearance on 2026-08-24. The listed applicant is DentalMaster(Xiamen)Medical Technology Co., Ltd.. The 510(k) number is K254286.

When did Guided Bone Regeneration System receive FDA 510(k) clearance?

Guided Bone Regeneration System received FDA 510(k) clearance on 2026-08-24, under 510(k) number K254286.

Who is the listed applicant for Guided Bone Regeneration System?

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

What is the FDA product code for Guided Bone Regeneration System?

The FDA product code for Guided Bone Regeneration System is DZL.

Related Clinical Trials

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.

NCT05275192Utilization of a Videoscope in Periodontal RegenerationACTIVE_NOT_RECRUITINGNCT05437757Scaffold-guided Breast SurgeryCOMPLETEDNCT06059898Magnesium NOVAMag® Membrane vs. Collagen Jason® Membrane in Patients Requiring Guided Bone RegenerationCOMPLETEDNCT07032259Regenerative Outcomes for Peri-implant Bony Defects Using Amnion-chorion Barrier vs. Collagen MembraneNOT_YET_RECRUITINGNCT07520903Titanium-Reinforced PTFE Membranes for Bone AugmentationCOMPLETEDNCT07529444Microbiological Evaluation of the Effectiveness of Different Surface Decontamination Protocols for Dental ImplantsRECRUITING

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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