QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM— 510(k) K002241

Name: FDA 510(k) clearance K002241
Creator: U.S. Food and Drug Administration
Published: 2001-09-20

Substantially Equivalent

Quantum Bioengineering, Ltd.

FDA 510(k) clearance K002241 for QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM, Substantially Equivalent on 2001-09-20. Applicant: Quantum Bioengineering, Ltd.. Device class: 2.

Clearance details

Applicant: Quantum Bioengineering, Ltd.
Product code: Code DZE
Device class: Class 2
Regulation: 21 CFR 872.3640
Advisory panel: Dental
Date received: 2000-07-24
Decision date: 2001-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plantation, FL, 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 Quantum Bioengineering, Ltd.

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K130787 — QUANTUM DENTAL IMPLANT SYSTEM2013-06-13
K112279 — QUANTUM DENTAL IMPLANT SYSTEM2012-05-04
K991250 — QUANTUM VERSATILITY IMPLANT SYSTEM2001-09-20

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.