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FDA 510(k)

LIGHTSPEED DENTAL HAND INSTRUMENT

K-Number: K932529 · 1993-11-04

ApplicantLightspeed Endodontics
Decision Date1993-11-04
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIGHTSPEED DENTAL HAND INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Lightspeed Endodontics. It received FDA 510(k) clearance on 1993-11-04 under 510(k) number K932529. 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 LIGHTSPEED DENTAL HAND INSTRUMENT?

LIGHTSPEED DENTAL HAND INSTRUMENT is a medical device that received FDA 510(k) clearance on 1993-11-04. The listed applicant is Lightspeed Endodontics. The 510(k) number is K932529.

When did LIGHTSPEED DENTAL HAND INSTRUMENT receive FDA 510(k) clearance?

LIGHTSPEED DENTAL HAND INSTRUMENT received FDA 510(k) clearance on 1993-11-04, under 510(k) number K932529.

Who is the listed applicant for LIGHTSPEED DENTAL HAND INSTRUMENT?

The FDA 510(k) record lists Lightspeed Endodontics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LIGHTSPEED DENTAL HAND INSTRUMENT?

The FDA product code for LIGHTSPEED DENTAL HAND INSTRUMENT is EKS.

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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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