510(k) K180477
K180477 is an FDA 510(k) premarket notification submitted by Institut Straumann AG for the device "Straumann PURE Ceramic Implant System". The FDA issued a decision of Substantially Equivalent on Jan 4, 2019. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Institut Straumann AG has 91 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 4, 2019
- Date Received
- Feb 22, 2018
- 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)