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)

RECOH ROOT CANAL IRRIGATOR

K-Number: K811175 · 1981-05-27

ApplicantKoei International, Inc.
Decision Date1981-05-27
Product CodeEFS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

RECOH ROOT CANAL IRRIGATOR is the device name listed in this FDA 510(k) record. The listed applicant is Koei International, Inc.. It received FDA 510(k) clearance on 1981-05-27 under 510(k) number K811175. The device is classified under product code EFS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECOH ROOT CANAL IRRIGATOR?

RECOH ROOT CANAL IRRIGATOR is a medical device that received FDA 510(k) clearance on 1981-05-27. The listed applicant is Koei International, Inc.. The 510(k) number is K811175.

When did RECOH ROOT CANAL IRRIGATOR receive FDA 510(k) clearance?

RECOH ROOT CANAL IRRIGATOR received FDA 510(k) clearance on 1981-05-27, under 510(k) number K811175.

Who is the listed applicant for RECOH ROOT CANAL IRRIGATOR?

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

What is the FDA product code for RECOH ROOT CANAL IRRIGATOR?

The FDA product code for RECOH ROOT CANAL IRRIGATOR is EFS.

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

Related Devices (Code: EFS)

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.

K023232SPLATRFREE SWANGLE 360 DISPOSABLE PROPHYLAXIS ANGLESmartpracticeK001493DENTAL AIR FORCE HOME DENTAL CLEANING SYSTEM, MODEL NO. 0020001Air Force, Inc.K983374AGATHA-A-H2010Midian Intl.K964810DERMADAMUltradent Products, Inc.K952234BARRIER ALL FILMCottrell, Ltd.K943182ORAL-B PERIOFLEX SUBGINGIVAL IRRIGATOROral-B Laboratories

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.

↑