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FDA 510(k)

HygePLUS Alginate Impression Material

K-Number: K170812 · 2017-07-26

ApplicantHygedent, Inc.
Decision Date2017-07-26
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HygePLUS Alginate Impression Material is the device name listed in this FDA 510(k) record. The listed applicant is Hygedent, Inc.. It received FDA 510(k) clearance on 2017-07-26 under 510(k) number K170812. 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 HygePLUS Alginate Impression Material?

HygePLUS Alginate Impression Material is a medical device that received FDA 510(k) clearance on 2017-07-26. The listed applicant is Hygedent, Inc.. The 510(k) number is K170812.

When did HygePLUS Alginate Impression Material receive FDA 510(k) clearance?

HygePLUS Alginate Impression Material received FDA 510(k) clearance on 2017-07-26, under 510(k) number K170812.

Who is the listed applicant for HygePLUS Alginate Impression Material?

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

What is the FDA product code for HygePLUS Alginate Impression Material?

The FDA product code for HygePLUS Alginate Impression Material is ELW.

Other records listing Hygedent, Inc. 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.

K203824VPS Impression MaterialK191034VPS Impression Material

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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