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FDA 510(k)

LC ResinCal PC

K-Number: K202413 · 2020-11-20

ApplicantS&C Polymer Silicon- Und Composite Spezialitaten GmbH
Decision Date2020-11-20
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LC ResinCal PC is the device name listed in this FDA 510(k) record. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitaten GmbH. It received FDA 510(k) clearance on 2020-11-20 under 510(k) number K202413. 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 LC ResinCal PC?

LC ResinCal PC is a medical device that received FDA 510(k) clearance on 2020-11-20. The listed applicant is S&C Polymer Silicon- Und Composite Spezialitaten GmbH. The 510(k) number is K202413.

When did LC ResinCal PC receive FDA 510(k) clearance?

LC ResinCal PC received FDA 510(k) clearance on 2020-11-20, under 510(k) number K202413.

Who is the listed applicant for LC ResinCal PC?

The FDA 510(k) record lists S&C Polymer Silicon- Und Composite Spezialitaten GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LC ResinCal PC?

The FDA product code for LC ResinCal PC is EJK.

Other records listing S&C Polymer Silicon- Und Composite Spezialitaten GmbH 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.

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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 LimitedK201799CleaniCalMaruchiK191103Parkell Desensitizer GelParkell, 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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