PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS)— 510(k) K220841

Name: FDA 510(k) clearance K220841
Creator: U.S. Food and Drug Administration
Published: 2022-11-16

Substantially Equivalent

Dentsply Sirona

FDA 510(k) clearance K220841 for PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS), Substantially Equivalent on 2022-11-16. Applicant: Dentsply Sirona. Device class: 2.

Clearance details

Applicant: Dentsply Sirona
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2022-03-23
Decision date: 2022-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, US

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

More clearances from Dentsply Sirona

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K262127 — DS Core CBCT Anatomy2026-08-21
K260785 — DS Core CBCT Anatomy2026-04-23
K253959 — Primevision 3D2026-02-05
K252343 — Atlantis® Abutments in Titanium2025-12-09
K252248 — CEREC Tessera Abutment System2025-11-26

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.