# K173706: Piccolo Implants and Accessories

- Pathway: 510(k) (Traditional)
- Applicant: Southern Implants (Pty), Ltd.
- Decided: Jun 8, 2018 after 186 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: 13 generations back to K894595 (1990). 187 ancestors in all.
No later device cites it as a predicate yet.
0 of 188 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163060: Deep Conical (DC) Implants and Accessories, Southern Implants (Pty), Ltd. (2017) Summary page 4.

## Indications for use
The Piccolo Implants and Accessories are intended for both one- and two-stage surgical procedures in the following situations and with the following clinical protocols: • replacing maxillary lateral incisors and mandibular incisors, • immediate placement in extraction sites and in situations with a partially or completely healed alveolar ridge, • immediate loading when good primary stability with appropriate occlusal loading is achieved, except in soft bone (type IV) where implant stability may be difficult to obtain.

Source page: https://510kreport.com/device/K173706
Methodology: https://510kreport.com/methodology