510(k) K211409
K211409 is an FDA 510(k) premarket notification submitted by Quadric Biomed, LLC for the device "Proximerge 2 Dental Implant System". The FDA issued a decision of Substantially Equivalent on Oct 19, 2022. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 19, 2022
- Date Received
- May 6, 2021
- 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)