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FDA 510(k)

VPS Impression Material

K-Number: K191034 · 2019-09-04

ApplicantHygedent, Inc.
Decision Date2019-09-04
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VPS Impression Material is a medical device manufactured by Hygedent, Inc.. It received FDA 510(k) clearance on 2019-09-04 under approval number K191034. 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 VPS Impression Material?

VPS Impression Material is a medical device that received FDA 510(k) clearance on 2019-09-04. It is manufactured by Hygedent, Inc.. The 510(k) number is K191034.

When was VPS Impression Material approved by the FDA?

VPS Impression Material received FDA 510(k) clearance on 2019-09-04, under approval number K191034.

What company makes VPS Impression Material?

VPS Impression Material is manufactured by Hygedent, Inc..

What is the FDA product code for VPS Impression Material?

The FDA product code for VPS Impression Material is ELW.

Other Devices by Hygedent, Inc.

K170812HygePLUS Alginate Impression Material K203824VPS Impression Material

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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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