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)

EXCEL HIGH SPEED DENTAL HANDPIECE

K-Number: K061581 · 2006-08-16

ApplicantOrthosource, Inc.
Decision Date2006-08-16
Product CodeEFA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

EXCEL HIGH SPEED DENTAL HANDPIECE is the device name listed in this FDA 510(k) record. The listed applicant is Orthosource, Inc.. It received FDA 510(k) clearance on 2006-08-16 under 510(k) number K061581. The device is classified under product code EFA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXCEL HIGH SPEED DENTAL HANDPIECE?

EXCEL HIGH SPEED DENTAL HANDPIECE is a medical device that received FDA 510(k) clearance on 2006-08-16. The listed applicant is Orthosource, Inc.. The 510(k) number is K061581.

When did EXCEL HIGH SPEED DENTAL HANDPIECE receive FDA 510(k) clearance?

EXCEL HIGH SPEED DENTAL HANDPIECE received FDA 510(k) clearance on 2006-08-16, under 510(k) number K061581.

Who is the listed applicant for EXCEL HIGH SPEED DENTAL HANDPIECE?

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

What is the FDA product code for EXCEL HIGH SPEED DENTAL HANDPIECE?

The FDA product code for EXCEL HIGH SPEED DENTAL HANDPIECE is EFA.

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 Orthosource, 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.

K061897EXCEL CONTRA ANGLE HANDPIECE

Related Devices (Code: EFA)

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.

K192809Dental HandpieceMicro-Nx Co., Ltd.K163239SMARTmaticKaltenbach & Voigt GmbHK101172RDT3 HANDPIECE HEAD MODEL RDT3Redent Nova, Ltd.K093894ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLEAnthogyrK092446INTRA LUX HEAD 3 LDSYKaltenbach & Voigt GmbH & Co.K090055LOW & HIGH SPEED KITDpm USA 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.

↑