HySil Super Fast Impression Materials
K-Number: K192941 · 2020-01-30
ApplicantOsstem Implant Co., Ltd.
Decision Date2020-01-30
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HySil Super Fast Impression Materials is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2020-01-30 under approval 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. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K192941.
When was HySil Super Fast Impression Materials approved by the FDA?
HySil Super Fast Impression Materials received FDA 510(k) clearance on 2020-01-30, under approval number K192941.
What company makes HySil Super Fast Impression Materials?
HySil Super Fast Impression Materials is manufactured by Osstem Implant Co., Ltd..
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 Devices by Osstem Implant Co., Ltd.
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.