K210711 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Yomi Plan v2.0.1. This device is classified as a Dental Stereotaxic Instrument (Class II - Special Controls, product code PLV).
Submitted by Neocis, Inc. (Miami, US). The FDA issued a Cleared decision on December 22, 2021, 287 days after receiving the submission on March 10, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120. To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous..
| 510(k) Number | K210711 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 10, 2021 |
| Decision Date | December 22, 2021 |
| Days to Decision | 287 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | PLV - Dental Stereotaxic Instrument |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |
| Definition | To Facilitate Dental Implant Placement In Patients That Are Partially Endentulous Or Edentulous. |