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FDA 510(k)

ROOT CANAL ORGANIZER

K-Number: K860817 · 1986-03-17

ApplicantPacific Union Dental, Inc.
Decision Date1986-03-17
Product CodeEIK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ROOT CANAL ORGANIZER is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Union Dental, Inc.. It received FDA 510(k) clearance on 1986-03-17 under 510(k) number K860817. The device is classified under product code EIK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROOT CANAL ORGANIZER?

ROOT CANAL ORGANIZER is a medical device that received FDA 510(k) clearance on 1986-03-17. The listed applicant is Pacific Union Dental, Inc.. The 510(k) number is K860817.

When did ROOT CANAL ORGANIZER receive FDA 510(k) clearance?

ROOT CANAL ORGANIZER received FDA 510(k) clearance on 1986-03-17, under 510(k) number K860817.

Who is the listed applicant for ROOT CANAL ORGANIZER?

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

What is the FDA product code for ROOT CANAL ORGANIZER?

The FDA product code for ROOT CANAL ORGANIZER is EIK.

Related Clinical Trials

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Other records listing Pacific Union Dental, 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.

K863500STAINLESS STEEL DEN. CROWN REMOVER & AMA./COMP.CARK855112DISPOSABLE 3IN CHECK BITE IMPRESSION TRAYSK855111DISPOSABLE PLASTIC DENT IMPRESSION TRAYS 9 STYLESK855113FLOSS HOLDER (PLASTIC)

Related Devices (Code: EIK)

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.

K013993NEOCALEXStephen M Koral, DmdK972642PERIO CONTROL IIEstrad B.V.K902653PDS-2000Intl. Equipment and Supply Corp.K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia

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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