K211872 is an FDA 510(k) clearance for the PiezoImplant System. This device is classified as a Blade-form Endosseous Dental Implant (Class II - Special Controls, product code NRQ).
Submitted by Rex Implants, Inc. (Columbus, US). The FDA issued a Cleared decision on October 12, 2022, 482 days after receiving the submission on June 17, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3640. Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's Chewing Function..
| 510(k) Number | K211872 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 2021 |
| Decision Date | October 12, 2022 |
| Days to Decision | 482 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NRQ - Blade-form Endosseous Dental Implant |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3640 |
| Definition | Device Made Of A Material Such As Titanium Or Titanium Alloy, That Is Intended To Be Surgically Placed In The Bone Of The Upper Or Lower Jaw Arches To Provide Support For Prosthetic Devices, Such As Artificial Teeth, In Order To Restore A Patient's Chewing Function. |