HySil Impression Materials
K-Number: K181236 · 2018-09-13
Device Summary
Frequently Asked Questions
What is the HySil Impression Materials?
HySil Impression Materials is a medical device that received FDA 510(k) clearance on 2018-09-13. The listed applicant is Osstem Implant Co., Ltd.. The 510(k) number is K181236.
When did HySil Impression Materials receive FDA 510(k) clearance?
HySil Impression Materials received FDA 510(k) clearance on 2018-09-13, under 510(k) number K181236.
Who is the listed applicant for HySil Impression Materials?
The FDA 510(k) record lists Osstem Implant Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for HySil Impression Materials?
The FDA product code for HySil Impression Materials is ELW.
Other records listing Osstem Implant Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: ELW)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.