# K183024: Implacil Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implacil DE Bortoli Material Odontologico Ltda
- Decided: Feb 13, 2020 after 469 days
- Product code: DZE (Implant, Endosseous, Root-Form)
- Device class: 2
- Regulation: 21 CFR 872.3640
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 16 generations back to K960026 (1996). 399 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 402 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170398: S.I.N. Dental Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 4.
- K062931: Implus Implant System, Leader Italia S.R.L. (2007) Summary page 4.
- K072642: Biomet 3I Dental Abutments and Restorative Components, Biomet 3i, Inc. (2007) Summary page 4.
- K090452: Neoss Implant System 03.25, Neoss, Ltd. (2009) Summary page 4.
- K101207: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2010) Summary page 4.
- K101945: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2011) Summary page 4.
- K133510: Neodent Implant System, Jj Industria E Comercio DE Materiais Dentarios SA (2014) Summary page 5.
- K140440: Noris Medical Dental Implants System, Noris Medical, Ltd. (2014) Summary page 5.
- K163060: Deep Conical (DC) Implants and Accessories, Southern Implants (Pty), Ltd. (2017) Summary page 5.
- K163634: External Hex Implants, Southern Implants (Pty), Ltd. (2017) Summary page 5.
- K170392: S.I.N. Implant System, S.I.N. – Sistema DE Implante Nacional S.A. (2017) Summary page 5.
- K170608: UF (II) Implant System, Dio Corporation (2018) Summary page 5.
- K173819: MyPlant II Implant System, Hager& Meisinger GmbH (2018) Summary page 5.
- K173902: Neodent Implant System – GM Line, Jjgc Industria E Comercio DE Materiais Dentarios S.A. (2018) Summary page 5.
- K180282: MIS Internal Hex Dental Implant System, Mis Implants Technologies, Ltd. (2018) Summary page 5.

## Most influential descendants
- K202832: Implacil Implant System (2021), 0 descendants of its own
- K192839: DSP Implant System (2021), 0 descendants of its own

## Indications for use
Implacil Implant System is intended for placement in the maxillary or mandibular arch to provide support for single-unit and/or multi-unit restorations. When a one-stage surgical approach is applied, the Implacil Implant System is intended for immediate loading when good primary stability is achieved and with appropriate occlusal loading.

Source page: https://510kreport.com/device/K183024
Methodology: https://510kreport.com/methodology