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FDA 510(k)

NEOCALEX

K-Number: K013993 · 2002-02-22

ApplicantStephen M Koral, Dmd
Decision Date2002-02-22
Product CodeEIK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NEOCALEX is the device name listed in this FDA 510(k) record. The listed applicant is Stephen M Koral, Dmd. It received FDA 510(k) clearance on 2002-02-22 under 510(k) number K013993. 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 NEOCALEX?

NEOCALEX is a medical device that received FDA 510(k) clearance on 2002-02-22. The listed applicant is Stephen M Koral, Dmd. The 510(k) number is K013993.

When did NEOCALEX receive FDA 510(k) clearance?

NEOCALEX received FDA 510(k) clearance on 2002-02-22, under 510(k) number K013993.

Who is the listed applicant for NEOCALEX?

The FDA 510(k) record lists Stephen M Koral, Dmd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEOCALEX?

The FDA product code for NEOCALEX is EIK.

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.

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Other records listing Stephen M Koral, Dmd 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.

K010176CALEX CONDITIONER

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.

K972642PERIO CONTROL IIEstrad B.V.K902653PDS-2000Intl. Equipment and Supply Corp.K860817ROOT CANAL ORGANIZERPacific Union Dental, Inc.K8517272020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CAArtiberia

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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