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FDA 510(k)

BONE DRILL

K-Number: K945706 · 1995-07-14

ApplicantOsteo Implant Corp.
Decision Date1995-07-14
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONE DRILL is the device name listed in this FDA 510(k) record. The listed applicant is Osteo Implant Corp.. It received FDA 510(k) clearance on 1995-07-14 under 510(k) number K945706. The device is classified under product code DZE. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONE DRILL?

BONE DRILL is a medical device that received FDA 510(k) clearance on 1995-07-14. The listed applicant is Osteo Implant Corp.. The 510(k) number is K945706.

When did BONE DRILL receive FDA 510(k) clearance?

BONE DRILL received FDA 510(k) clearance on 1995-07-14, under 510(k) number K945706.

Who is the listed applicant for BONE DRILL?

The FDA 510(k) record lists Osteo Implant Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BONE DRILL?

The FDA product code for BONE DRILL is DZE.

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

Other records listing Osteo Implant Corp. 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.

K862854OSTEO TITANIUM DENTAL IMPLANT

Related Devices (Code: DZE)

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.

K261392TriActive Dental Implant SystemParagon Implant Mfg., LLCK260463ZEROS Dental Implant SystemZeros Co., Ltd.K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd.K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd.K250806Dental Implant SystemA.B. Dental Devices , Ltd.K260006INOSS SystemInosys, Inc.

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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