# K202832: Implacil Implant System

- Pathway: 510(k) (Traditional)
- Applicant: Implacil DE Bortoli Material Odontologico Ltda
- Decided: May 26, 2021 after 243 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: 17 generations back to K960026 (1996). 400 ancestors in all.
No later device cites it as a predicate yet.
0 of 401 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183024: Implacil Implant System, Implacil DE Bortoli Material Odontologico Ltda (2020) Summary page 4.

## 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/K202832
Methodology: https://510kreport.com/methodology