K200805 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Patient Splints. 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 July 28, 2020, 123 days after receiving the submission on March 27, 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 | K200805 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 27, 2020 |
| Decision Date | July 28, 2020 |
| Days to Decision | 123 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. |