K202100 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS). 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 October 19, 2020, 82 days after receiving the submission on July 29, 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 | K202100 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 29, 2020 |
| Decision Date | October 19, 2020 |
| Days to Decision | 82 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. |