# Avinent Implant System S.L.U.

- Location (FDA's records): Santpedor, ES
- FDA decisions: 3 (2020–2026): 3 510(k) clearances
- Product codes: KCT (2), NXC (1)
- 510(k) review time since 2016: median 266 days, against 134 for FDA's reviews in the same codes and years (0 of 3 faster)
- Predicates its devices cite: 3 (1 its own); citations of its devices by later devices: 2 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Implant Direct Sybron Manufacturing, LLC: 1 (https://510kreport.com/company/implant-direct-sybron-manufacturing)
- Kline Europe GmbH: 1 (https://510kreport.com/company/kline-europe)

## Firms that cite its devices most
- Biotech Dental, Sas: 1 (https://510kreport.com/company/biotech-dental)

## Its most-cited devices
- K191566: Avinent Surgical Tray (2020), cited by 2

## Recent decisions
- K260527: FACE4D Aligner (Jul 2, 2026)
- K201533: Avinent Biomimetic Coral and Ocean-Iceberg Sterilization Cassettes (Mar 1, 2021)
- K191566: Avinent Surgical Tray (Mar 6, 2020)

Source page: https://510kreport.com/company/avinent-implant-system-slu