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)

MAXIMUS OS (OVERDENTURE SYSTEM)

K-Number: K041938 · 2004-07-22

ApplicantBioHorizons Implant Systems, Inc.
Decision Date2004-07-22
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MAXIMUS OS (OVERDENTURE SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is BioHorizons Implant Systems, Inc.. It received FDA 510(k) clearance on 2004-07-22 under 510(k) number K041938. 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 MAXIMUS OS (OVERDENTURE SYSTEM)?

MAXIMUS OS (OVERDENTURE SYSTEM) is a medical device that received FDA 510(k) clearance on 2004-07-22. The listed applicant is BioHorizons Implant Systems, Inc.. The 510(k) number is K041938.

When did MAXIMUS OS (OVERDENTURE SYSTEM) receive FDA 510(k) clearance?

MAXIMUS OS (OVERDENTURE SYSTEM) received FDA 510(k) clearance on 2004-07-22, under 510(k) number K041938.

Who is the listed applicant for MAXIMUS OS (OVERDENTURE SYSTEM)?

The FDA 510(k) record lists BioHorizons Implant Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAXIMUS OS (OVERDENTURE SYSTEM)?

The FDA product code for MAXIMUS OS (OVERDENTURE SYSTEM) 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 BioHorizons Implant Systems, Inc. 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.

K260061BioHorizons CEREC Compatible Ti-BasesK243521Conical Ti Base abutmentsK240531SmartShape™ Healing Abutment; Wide Custom Milled Ti-Blank AbutmentK240187Tapered Pro Conical Implant SystemK223697MRI compatibility for existing BioHorizons dental implants and abutmentsK203252Multi-unit Abutments for CONELOG

View all 40 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑