MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm— 510(k) K171728

Name: FDA 510(k) clearance K171728
Creator: U.S. Food and Drug Administration
Published: 2017-09-28

Substantially Equivalent

Sterngold Dental, LLC

FDA 510(k) clearance K171728 for MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm, Substantially Equivalent on 2017-09-28. Applicant: Sterngold Dental, LLC. Device class: 2.

Clearance details

Applicant: Sterngold Dental, LLC
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2017-06-12
Decision date: 2017-09-28
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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K153173 — MOR Implant System2016-02-05
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K142667 — Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm2015-01-07

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.