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 a medical device manufactured by Hygedent, Inc.. It received FDA 510(k) clearance on 2017-07-26 under approval 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. It is manufactured by Hygedent, Inc.. The 510(k) number is K170812.
When was HygePLUS Alginate Impression Material approved by the FDA?
HygePLUS Alginate Impression Material received FDA 510(k) clearance on 2017-07-26, under approval number K170812.
What company makes HygePLUS Alginate Impression Material?
HygePLUS Alginate Impression Material is manufactured by Hygedent, Inc..
What is the FDA product code for HygePLUS Alginate Impression Material?
The FDA product code for HygePLUS Alginate Impression Material is ELW.
Other Devices by Hygedent, Inc.
Related Devices (Code: ELW)
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.