FDA 510(k)

ENDEX REAMERS PULP CANAL, ENDODONTIC

K-Number: K800291 · 1980-02-19

Decision Date1980-02-19

Product CodeEKP

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ENDEX REAMERS PULP CANAL, ENDODONTIC is the device name listed in this FDA 510(k) record. The listed applicant is Ipco Corp.. It received FDA 510(k) clearance on 1980-02-19 under 510(k) number K800291. The device is classified under product code EKP. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENDEX REAMERS PULP CANAL, ENDODONTIC?

ENDEX REAMERS PULP CANAL, ENDODONTIC is a medical device that received FDA 510(k) clearance on 1980-02-19. The listed applicant is Ipco Corp.. The 510(k) number is K800291.

When did ENDEX REAMERS PULP CANAL, ENDODONTIC receive FDA 510(k) clearance?

ENDEX REAMERS PULP CANAL, ENDODONTIC received FDA 510(k) clearance on 1980-02-19, under 510(k) number K800291.

Who is the listed applicant for ENDEX REAMERS PULP CANAL, ENDODONTIC?

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

What is the FDA product code for ENDEX REAMERS PULP CANAL, ENDODONTIC?

The FDA product code for ENDEX REAMERS PULP CANAL, ENDODONTIC is EKP.

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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.