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)

REAMER TYPE K ENDODONTIC

K-Number: K823686 · 1982-12-28

ApplicantUnited Dental Mfg., Inc.
Decision Date1982-12-28
Product CodeEKP
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

REAMER TYPE K ENDODONTIC is the device name listed in this FDA 510(k) record. The listed applicant is United Dental Mfg., Inc.. It received FDA 510(k) clearance on 1982-12-28 under 510(k) number K823686. 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 REAMER TYPE K ENDODONTIC?

REAMER TYPE K ENDODONTIC is a medical device that received FDA 510(k) clearance on 1982-12-28. The listed applicant is United Dental Mfg., Inc.. The 510(k) number is K823686.

When did REAMER TYPE K ENDODONTIC receive FDA 510(k) clearance?

REAMER TYPE K ENDODONTIC received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823686.

Who is the listed applicant for REAMER TYPE K ENDODONTIC?

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

What is the FDA product code for REAMER TYPE K ENDODONTIC?

The FDA product code for REAMER TYPE K ENDODONTIC 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

Other records listing United Dental Mfg., 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.

K843017ABSORBENT ENDODONTIC POINTK823684FILE TYPE K ENDODONTICK823685FILE TYPE H (HEDSTROEM) ENDODONTICK812886ENDODONTIC PAPER POINTS

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.

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 RandolphK770367ROOT CANAL FILES & REAMERSCemco Tool Co., 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.

↑