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)

ROOT CANAL FILES & REAMERS

K-Number: K770367 · 1977-03-01

ApplicantCemco Tool Co., Inc.
Decision Date1977-03-01
Product CodeEKP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL FILES & REAMERS is the device name listed in this FDA 510(k) record. The listed applicant is Cemco Tool Co., Inc.. It received FDA 510(k) clearance on 1977-03-01 under 510(k) number K770367. The device is classified under product code EKP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL FILES & REAMERS?

ROOT CANAL FILES & REAMERS is a medical device that received FDA 510(k) clearance on 1977-03-01. The listed applicant is Cemco Tool Co., Inc.. The 510(k) number is K770367.

When did ROOT CANAL FILES & REAMERS receive FDA 510(k) clearance?

ROOT CANAL FILES & REAMERS received FDA 510(k) clearance on 1977-03-01, under 510(k) number K770367.

Who is the listed applicant for ROOT CANAL FILES & REAMERS?

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

What is the FDA product code for ROOT CANAL FILES & REAMERS?

The FDA product code for ROOT CANAL FILES & REAMERS is EKP.

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: EKP)

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.

K823686REAMER TYPE K ENDODONTICUnited Dental Mfg., Inc.K822620ROOT CANAL REAMERS, TYPE KUnion Broach, Div. Moyco Industries, Inc.K800291ENDEX REAMERS PULP CANAL, ENDODONTICIpco Corp.K770331DIALYSIS, JET SYSTEMJanneck Ent. of TexasK770598ENDODONTIC INSTRUMENTS, R&R CUTWELLRansom and Randolph

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.

↑