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FDA 510(k)

HySil Super Fast Impression Materials

K-Number: K192941 · 2020-01-30

Decision Date2020-01-30
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HySil Super Fast Impression Materials is the device name listed in this FDA 510(k) record. The listed applicant is Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2020-01-30 under 510(k) number K192941. 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 HySil Super Fast Impression Materials?

HySil Super Fast Impression Materials is a medical device that received FDA 510(k) clearance on 2020-01-30. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K192941.

When did HySil Super Fast Impression Materials receive FDA 510(k) clearance?

HySil Super Fast Impression Materials received FDA 510(k) clearance on 2020-01-30, under 510(k) number K192941.

Who is the listed applicant for HySil Super Fast Impression Materials?

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

What is the FDA product code for HySil Super Fast Impression Materials?

The FDA product code for HySil Super Fast Impression Materials is ELW.

Other records listing Osstem Implant Co., Ltd. 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.

View all 31 devices →

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.

Official Source

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