Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

BIORESORB MACRO PORE

K-Number: K050260 · 2005-07-15

ApplicantOraltronics Dental Implant Technology GmbH
Decision Date2005-07-15
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BIORESORB MACRO PORE is the device name listed in this FDA 510(k) record. The listed applicant is Oraltronics Dental Implant Technology GmbH. It received FDA 510(k) clearance on 2005-07-15 under 510(k) number K050260. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIORESORB MACRO PORE?

BIORESORB MACRO PORE is a medical device that received FDA 510(k) clearance on 2005-07-15. The listed applicant is Oraltronics Dental Implant Technology GmbH. The 510(k) number is K050260.

When did BIORESORB MACRO PORE receive FDA 510(k) clearance?

BIORESORB MACRO PORE received FDA 510(k) clearance on 2005-07-15, under 510(k) number K050260.

Who is the listed applicant for BIORESORB MACRO PORE?

The FDA 510(k) record lists Oraltronics Dental Implant Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BIORESORB MACRO PORE?

The FDA product code for BIORESORB MACRO PORE is LYC.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: LYC)

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.

K253317Cytrans™ ElashieldGC America, Inc.K253883Bonalive MaxillofacialBonalive , Ltd.K251818BONTREE PLUSHudens Bio Co., Ltd.K244006FG Bone Graft MFull Golden Biotech Co., Ltd.K243745FG Bone Graft BFull Golden Biotech CorporationK241186Synthetic Bone Graft ParticulateShenzhen Dazhou Medical Technology Co., Ltd.

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.

↑