HySil Plus Impression Materials
K-Number: K210041 · 2021-03-18
ApplicantOsstem Implant Co., Ltd.
Decision Date2021-03-18
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HySil Plus Impression Materials is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2021-03-18 under approval number K210041. 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 Plus Impression Materials?
HySil Plus Impression Materials is a medical device that received FDA 510(k) clearance on 2021-03-18. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K210041.
When was HySil Plus Impression Materials approved by the FDA?
HySil Plus Impression Materials received FDA 510(k) clearance on 2021-03-18, under approval number K210041.
What company makes HySil Plus Impression Materials?
HySil Plus Impression Materials is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for HySil Plus Impression Materials?
The FDA product code for HySil Plus 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.