HySil Impression Materials
K-Number: K170736 · 2017-06-07
ApplicantOsstem Implant Co., Ltd.
Decision Date2017-06-07
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HySil Impression Materials is a medical device manufactured by Osstem Implant Co., Ltd.. It received FDA 510(k) clearance on 2017-06-07 under approval number K170736. 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 Impression Materials?
HySil Impression Materials is a medical device that received FDA 510(k) clearance on 2017-06-07. It is manufactured by Osstem Implant Co., Ltd.. The 510(k) number is K170736.
When was HySil Impression Materials approved by the FDA?
HySil Impression Materials received FDA 510(k) clearance on 2017-06-07, under approval number K170736.
What company makes HySil Impression Materials?
HySil Impression Materials is manufactured by Osstem Implant Co., Ltd..
What is the FDA product code for HySil Impression Materials?
The FDA product code for HySil 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.