Piccolo Implants and Accessories— 510(k) K173706

Name: FDA 510(k) clearance K173706
Creator: U.S. Food and Drug Administration
Published: 2018-06-08

Substantially Equivalent

Southern Implants (Pty), Ltd.

FDA 510(k) clearance K173706 for Piccolo Implants and Accessories, Substantially Equivalent on 2018-06-08. Applicant: Southern Implants (Pty), Ltd.. Device class: 2.

Clearance details

Applicant: Southern Implants (Pty), Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2017-12-04
Decision date: 2018-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guateng, ZA

Download summary PDF View on FDA.gov ↗

Recent devices under product code DZE

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K260463 — ZEROS Dental Implant System2026-08-19
K251188 — UNIQA® Dental Implants System2026-06-25
K250806 — Dental Implant System2026-06-18
K251232 — MegaGen Zygoma Dental Implant System2026-06-18
K260006 — INOSS System2026-06-17

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K230873 — Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments2023-08-01
K222469 — TIB Abutments2023-04-17
K222457 — Provata Implant System2023-03-06

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.