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FDA 510(k)

NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES

K-Number: K004031 · 2001-03-28

ApplicantDental Power, Inc.
Decision Date2001-03-28
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES is the device name listed in this FDA 510(k) record. The listed applicant is Dental Power, Inc.. It received FDA 510(k) clearance on 2001-03-28 under 510(k) number K004031. 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 NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES?

NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES is a medical device that received FDA 510(k) clearance on 2001-03-28. The listed applicant is Dental Power, Inc.. The 510(k) number is K004031.

When did NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES receive FDA 510(k) clearance?

NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES received FDA 510(k) clearance on 2001-03-28, under 510(k) number K004031.

Who is the listed applicant for NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES?

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

What is the FDA product code for NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES?

The FDA product code for NT SWIFT; TI\TEC; GATES GLIDDEN DRILLS; DENTAL POWER ENDODONTIC HAND FILES 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 Dental Power, 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.

K940680VERSADOWEL POST SYSTEM

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.K971319NT SERIES ENDODONTIC FILES, MAC SERIES ENDODONTIC FILESTycom DentalK970649HERO 642Micro-MegaK962031QUANTEC SERIES 2000 ENDODONTIC FILESTycom DentalK953604SHAPING HEDSTROM N.T.Sybron Dental Specialties, Inc.K935542NICKEL-TITANIUM K-TYPE FILEUnion Broach, Div. Moyco Industries, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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