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)

O BUTMENT ET IMPLANT

K-Number: K961665 · 1996-11-15

ApplicantO Co., Inc.
Decision Date1996-11-15
Product CodeDZE
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

O BUTMENT ET IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is O Co., Inc.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K961665. 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 O BUTMENT ET IMPLANT?

O BUTMENT ET IMPLANT is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is O Co., Inc.. The 510(k) number is K961665.

When did O BUTMENT ET IMPLANT receive FDA 510(k) clearance?

O BUTMENT ET IMPLANT received FDA 510(k) clearance on 1996-11-15, under 510(k) number K961665.

Who is the listed applicant for O BUTMENT ET IMPLANT?

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

What is the FDA product code for O BUTMENT ET IMPLANT?

The FDA product code for O BUTMENT ET IMPLANT 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 O Co., 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.

K033392IMMEDIATE STABILIZING IMPLANT (ISI)K023336OCO DENTAL IMPLANT (5.0MM DIAMETER)K021460OCO DENTAL IMPLANTK011524IMMEDIATE STABILIZING DEVICE (ISD)K010142OCO DENTAL IMPLANTK973926O BUTMENT HS IMPLANT

View all 17 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.

↑