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FDA 510(k)

FR ROOT CANAL SEALER

K-Number: K830764 · 1983-07-26

ApplicantShizai Corp.
Decision Date1983-07-26
Product CodeEKA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FR ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Shizai Corp.. It received FDA 510(k) clearance on 1983-07-26 under 510(k) number K830764. The device is classified under product code EKA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FR ROOT CANAL SEALER?

FR ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 1983-07-26. The listed applicant is Shizai Corp.. The 510(k) number is K830764.

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

FR ROOT CANAL SEALER received FDA 510(k) clearance on 1983-07-26, under 510(k) number K830764.

Who is the listed applicant for FR ROOT CANAL SEALER?

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

What is the FDA product code for FR ROOT CANAL SEALER?

The FDA product code for FR ROOT CANAL SEALER is EKA.

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 Shizai Corp. 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.

K830763FR ROOT CANAL FILLER

Related Devices (Code: EKA)

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.

K822464OBTURATION GUTTAU.S. Shizai Corp.

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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