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)

OSSEODENT DRILLING SYSTEM

K-Number: K862110 · 1986-08-07

ApplicantOtc/America
Decision Date1986-08-07
Product CodeKMW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OSSEODENT DRILLING SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Otc/America. It received FDA 510(k) clearance on 1986-08-07 under 510(k) number K862110. The device is classified under product code KMW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSSEODENT DRILLING SYSTEM?

OSSEODENT DRILLING SYSTEM is a medical device that received FDA 510(k) clearance on 1986-08-07. The listed applicant is Otc/America. The 510(k) number is K862110.

When did OSSEODENT DRILLING SYSTEM receive FDA 510(k) clearance?

OSSEODENT DRILLING SYSTEM received FDA 510(k) clearance on 1986-08-07, under 510(k) number K862110.

Who is the listed applicant for OSSEODENT DRILLING SYSTEM?

The FDA 510(k) record lists Otc/America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OSSEODENT DRILLING SYSTEM?

The FDA product code for OSSEODENT DRILLING SYSTEM is KMW.

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 Otc/America 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.

K860653PURE TITANIUM SCREW-TYPE FOR DENTAL IMPLANT

Related Devices (Code: KMW)

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.

K211584Oral Surgery ContraNakanishi, Inc.K171155Surgical Angle Handpiece, Surgical Straight HandpieceNakanishi, Inc.K162544OsteoMed PINNACLE DriverOsteomedK080939SURGICAL HANDPIECES, MIKRO SAW HANDPIECESW&H Dentalwerk Buermoos GmbHK994298FRIOS MICROSAWFriadent GmbHK971692OSTEOPOWER SYSTEM AND ACCESSORIESOsteomed Corp.

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.

↑