K202264 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Yomi Plan v2.0. 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 4, 2020, 115 days after receiving the submission on August 11, 2020.
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 | K202264 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 2020 |
| Decision Date | December 04, 2020 |
| Days to Decision | 115 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. |