510(k) K153332
K153332 is an FDA 510(k) premarket notification submitted by Hiossen, Inc. for the device "ETIII SA Fixture System (O3.2mm)". The FDA issued a decision of Substantially Equivalent on Oct 27, 2016. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Hiossen, Inc. has 25 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 27, 2016
- Date Received
- Nov 19, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Implant, Endosseous, Root-Form
- Device Class
- Class II
- Regulation Number
- 872.3640
- Review Panel
- DE
- Submission Type
- 510(k)