Neocis Guidance System (NGS) with Chairside Splint— 510(k) K173402
Substantially EquivalentNeocis, Inc.
FDA 510(k) clearance K173402 for Neocis Guidance System (NGS) with Chairside Splint, Substantially Equivalent on 2018-02-22. Applicant: Neocis, Inc.. Device class: 2.
Clearance details
- Applicant
- Neocis, Inc.
- Product code
- Code PLV
- Device class
- Class 2
- Regulation
- 21 CFR 872.4120
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
Recent devices under product code PLV
view allMore clearances from Neocis, Inc.
view allRecalls naming K173402
K-number listed on FDA's recall record- Z-0929-2021 — DRW-0739-01:Gen 2 Anterior Chairside Splint LRUL (lower right-upper left); accessories to the parent system, the Neocis Guidance System (NGS)
- Z-2637-2020 — DRW-0739-01: Gen 2 Posterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
- Z-2638-2020 — DRW-0739-02: Gen 2 Posterior Chairside Splint LRUL (lower right-upper left) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
- Z-2639-2020 — DRW-0742-01: Gen 2 Anterior Chairside Splint LLUR (lower left-upper right) - Product Usage: intended to provide assistance in both the planning (pre-operative) and the surgical (intra-operative) phases of dental implantation surgery.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K173402.
Data sourced from openFDA. This site is unofficial and independent of the FDA.