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FDA 510(k)

ABSORBENT ENDODONTIC POINT

K-Number: K843017 · 1985-01-09

ApplicantUnited Dental Mfg., Inc.
Decision Date1985-01-09
Product CodeEKN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ABSORBENT ENDODONTIC POINT 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 1985-01-09 under 510(k) number K843017. The device is classified under product code EKN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABSORBENT ENDODONTIC POINT?

ABSORBENT ENDODONTIC POINT is a medical device that received FDA 510(k) clearance on 1985-01-09. The listed applicant is United Dental Mfg., Inc.. The 510(k) number is K843017.

When did ABSORBENT ENDODONTIC POINT receive FDA 510(k) clearance?

ABSORBENT ENDODONTIC POINT received FDA 510(k) clearance on 1985-01-09, under 510(k) number K843017.

Who is the listed applicant for ABSORBENT ENDODONTIC POINT?

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 ABSORBENT ENDODONTIC POINT?

The FDA product code for ABSORBENT ENDODONTIC POINT is EKN.

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.

K823686REAMER TYPE K ENDODONTICK823684FILE TYPE K ENDODONTICK823685FILE TYPE H (HEDSTROEM) ENDODONTICK812886ENDODONTIC PAPER POINTS

Related Devices (Code: EKN)

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.

K821625ENDODONTIC PAPERPOINTSRoekoK812886ENDODONTIC PAPER POINTSUnited Dental Mfg., Inc.K800827PREMIER ABSORBENT POINTSPremier Dental Products Co.K781605R&R ABSORBENT POINTSRansom and RandolphK761203ABSORBENT POINTSJohnson & Johnson Professionals, Inc.K760983ENDODONTIC INSTRUMENTSAdp Intl., 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.

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