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FDA 510(k)

CALEX CONDITIONER

K-Number: K010176 · 2001-03-27

ApplicantStephen M Koral, Dmd
Decision Date2001-03-27
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CALEX CONDITIONER 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 2001-03-27 under 510(k) number K010176. The device is classified under product code EJK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALEX CONDITIONER?

CALEX CONDITIONER is a medical device that received FDA 510(k) clearance on 2001-03-27. The listed applicant is Stephen M Koral, Dmd. The 510(k) number is K010176.

When did CALEX CONDITIONER receive FDA 510(k) clearance?

CALEX CONDITIONER received FDA 510(k) clearance on 2001-03-27, under 510(k) number K010176.

Who is the listed applicant for CALEX CONDITIONER?

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 CALEX CONDITIONER?

The FDA product code for CALEX CONDITIONER is EJK.

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.

K013993NEOCALEX

Related Devices (Code: EJK)

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.

K261728One-Fil LCMediclus Co., Ltd.K253248Bright Cavity LinerDmp Dental Industry S.A.K2302703M™ VitCal Liner/Base3M Espe Dental ProductsK212475Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra)Prevest Denpro LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

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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