510(k) K210499
K210499 is an FDA 510(k) premarket notification submitted by Alpha Dent Implants GmbH for the device "Alpha Dent Implants Dental Implants System". The FDA issued a decision of Substantially Equivalent on November 1, 2021. The device falls under product code DZE (Implant, Endosseous, Root-Form), a Class II device regulated under 21 CFR 872.3640. Alpha Dent Implants GmbH has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 1, 2021
- Date Received
- February 22, 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