510(k) K192941
K192941 is an FDA 510(k) premarket notification submitted by Osstem Implant Co., Ltd. for the device "HySil Super Fast Impression Materials". The FDA issued a decision of Substantially Equivalent on January 30, 2020. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Osstem Implant Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 2020
- Date Received
- October 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Material, Impression
- Device Class
- Class II
- Regulation Number
- 872.3660
- Review Panel
- DE
- Submission Type