The following data is part of a premarket notification filed by Rex Implants, Inc. with the FDA for Piezoimplant System.
| Device ID | K211872 |
| 510k Number | K211872 |
| Device Name: | PiezoImplant System |
| Classification | Blade-form Endosseous Dental Implant |
| Applicant | Rex Implants, Inc. 850 Michigan Avenue Columbus, OH 43215 |
| Contact | Giuseppe Vercellotti |
| Correspondent | Karen E Warden BackRoads Consulting PO Box 566 Chesterland, OH 44026 *0566 |
| Product Code | NRQ |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-17 |
| Decision Date | 2022-10-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D894R4530 | K211872 | 000 |
| D894R2380 | K211872 | 000 |
| D894R1380 | K211872 | 000 |
| D894R4030 | K211872 | 000 |
| D894R4020 | K211872 | 000 |
| D894R4010 | K211872 | 000 |
| D894R4400 | K211872 | 000 |