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FDA 510(k)

FILE TYPE H (HEDSTROEM) ENDODONTIC

K-Number: K823685 · 1982-12-28

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

Device Summary

FILE TYPE H (HEDSTROEM) 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 K823685. The device is classified under product code EKS. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FILE TYPE H (HEDSTROEM) ENDODONTIC?

FILE TYPE H (HEDSTROEM) 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 K823685.

When did FILE TYPE H (HEDSTROEM) ENDODONTIC receive FDA 510(k) clearance?

FILE TYPE H (HEDSTROEM) ENDODONTIC received FDA 510(k) clearance on 1982-12-28, under 510(k) number K823685.

Who is the listed applicant for FILE TYPE H (HEDSTROEM) 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 FILE TYPE H (HEDSTROEM) ENDODONTIC?

The FDA product code for FILE TYPE H (HEDSTROEM) ENDODONTIC is EKS.

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 POINTK823686REAMER TYPE K ENDODONTICK823684FILE TYPE K ENDODONTICK812886ENDODONTIC PAPER POINTS

Related Devices (Code: EKS)

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.

K062856TF ROTARY NICKEL TITANIUM FILEOrmco Corp.K004031NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILESDental Power, Inc.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, 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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