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FDA 510(k)

DYNA TRAK ENDODONTIC PREP. INSTRUMENT

K-Number: K812260 · 1981-08-25

ApplicantInventive Technology Int'L., Inc.
Decision Date1981-08-25
Product CodeEKS
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DYNA TRAK ENDODONTIC PREP. INSTRUMENT is the device name listed in this FDA 510(k) record. The listed applicant is Inventive Technology Int'L., Inc.. It received FDA 510(k) clearance on 1981-08-25 under 510(k) number K812260. 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 DYNA TRAK ENDODONTIC PREP. INSTRUMENT?

DYNA TRAK ENDODONTIC PREP. INSTRUMENT is a medical device that received FDA 510(k) clearance on 1981-08-25. The listed applicant is Inventive Technology Int'L., Inc.. The 510(k) number is K812260.

When did DYNA TRAK ENDODONTIC PREP. INSTRUMENT receive FDA 510(k) clearance?

DYNA TRAK ENDODONTIC PREP. INSTRUMENT received FDA 510(k) clearance on 1981-08-25, under 510(k) number K812260.

Who is the listed applicant for DYNA TRAK ENDODONTIC PREP. INSTRUMENT?

The FDA 510(k) record lists Inventive Technology Int'L., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DYNA TRAK ENDODONTIC PREP. INSTRUMENT?

The FDA product code for DYNA TRAK ENDODONTIC PREP. 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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