510(k) K170812
K170812 is an FDA 510(k) premarket notification submitted by Hygedent, Inc. for the device "HygePLUS Alginate Impression Material". The FDA issued a decision of Substantially Equivalent on July 26, 2017. The device falls under product code ELW (Material, Impression), a Class II device regulated under 21 CFR 872.3660. Hygedent, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 26, 2017
- Date Received
- March 17, 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