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FDA 510(k)

CORRECT DENTAL IMPRESSION MATERIAL

K-Number: K042860 · 2004-12-03

ApplicantHandae Chemical Co., Ltd.
Decision Date2004-12-03
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CORRECT DENTAL IMPRESSION MATERIAL is the device name listed in this FDA 510(k) record. The listed applicant is Handae Chemical Co., Ltd.. It received FDA 510(k) clearance on 2004-12-03 under 510(k) number K042860. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORRECT DENTAL IMPRESSION MATERIAL?

CORRECT DENTAL IMPRESSION MATERIAL is a medical device that received FDA 510(k) clearance on 2004-12-03. The listed applicant is Handae Chemical Co., Ltd.. The 510(k) number is K042860.

When did CORRECT DENTAL IMPRESSION MATERIAL receive FDA 510(k) clearance?

CORRECT DENTAL IMPRESSION MATERIAL received FDA 510(k) clearance on 2004-12-03, under 510(k) number K042860.

Who is the listed applicant for CORRECT DENTAL IMPRESSION MATERIAL?

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

What is the FDA product code for CORRECT DENTAL IMPRESSION MATERIAL?

The FDA product code for CORRECT DENTAL IMPRESSION MATERIAL is ELW.

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Related Devices (Code: ELW)

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

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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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