K200348 is an FDA 510(k) clearance for the Neocis Guidance System (NGS) with Fiducial Array Splint (FAS). 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 May 8, 2020, 86 days after receiving the submission on February 12, 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 | K200348 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 12, 2020 |
| Decision Date | May 08, 2020 |
| Days to Decision | 86 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. |