510(k) K170736
K170736 is an FDA 510(k) premarket notification submitted by Osstem Implant Co., Ltd. for the device "HySil Impression Materials". The FDA issued a decision of Substantially Equivalent on Jun 7, 2017. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Osstem Implant Co., Ltd. has 67 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 2017
- Date Received
- Mar 10, 2017
- 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
- 510(k)