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FDA 510(k)

LINER, CAVITY CALCIUM HYDROXIDE

K-Number: K781688 · 1978-12-20

ApplicantKerr Corporation (Danbury)
Decision Date1978-12-20
Product CodeEJK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LINER, CAVITY CALCIUM HYDROXIDE is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1978-12-20 under 510(k) number K781688. 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 LINER, CAVITY CALCIUM HYDROXIDE?

LINER, CAVITY CALCIUM HYDROXIDE is a medical device that received FDA 510(k) clearance on 1978-12-20. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K781688.

When did LINER, CAVITY CALCIUM HYDROXIDE receive FDA 510(k) clearance?

LINER, CAVITY CALCIUM HYDROXIDE received FDA 510(k) clearance on 1978-12-20, under 510(k) number K781688.

Who is the listed applicant for LINER, CAVITY CALCIUM HYDROXIDE?

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

What is the FDA product code for LINER, CAVITY CALCIUM HYDROXIDE?

The FDA product code for LINER, CAVITY CALCIUM HYDROXIDE is EJK.

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Other records listing Kerr Corporation (Danbury) 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 LimitedK201799CleaniCalMaruchiK202413LC ResinCal PCS&C Polymer Silicon- Und Composite Spezialitaten GmbH

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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