510(k) K191605
K191605 is an FDA 510(k) premarket notification submitted by Neocis, Inc. for the device "Neocis Guidance System (NGS)". The FDA issued a decision of Substantially Equivalent on Sep 11, 2019. The device falls under product code PLV (Dental Stereotaxic Instrument), a Class II device regulated under 21 CFR 872.4120. Neocis, Inc. has 18 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 11, 2019
- Date Received
- Jun 17, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Dental Stereotaxic Instrument
- Device Class
- Class II
- Regulation Number
- 872.4120
- Review Panel
- DE
- Submission Type
- 510(k)
To facilitate dental implant placement in patients that are partially endentulous or edentulous.