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FDA 510(k)

ADSEAL ROOT CANAL SEALER

K-Number: K042769 · 2004-11-24

ApplicantMeta Biomed Co., Ltd.
Decision Date2004-11-24
Product CodeKIF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADSEAL ROOT CANAL SEALER is the device name listed in this FDA 510(k) record. The listed applicant is Meta Biomed Co., Ltd.. It received FDA 510(k) clearance on 2004-11-24 under 510(k) number K042769. The device is classified under product code KIF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ADSEAL ROOT CANAL SEALER?

ADSEAL ROOT CANAL SEALER is a medical device that received FDA 510(k) clearance on 2004-11-24. The listed applicant is Meta Biomed Co., Ltd.. The 510(k) number is K042769.

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

ADSEAL ROOT CANAL SEALER received FDA 510(k) clearance on 2004-11-24, under 510(k) number K042769.

Who is the listed applicant for ADSEAL ROOT CANAL SEALER?

The FDA 510(k) record lists Meta Biomed Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for ADSEAL ROOT CANAL SEALER is KIF.

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Other records listing Meta Biomed Co., Ltd. as applicant

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Related Devices (Code: KIF)

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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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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