Cleared Traditional

K002241 - QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM

K002241 is an FDA 510(k) clearance for QUANTUM VERSATILITY (QVS) DENTAL IMPLAN..., manufactured by Quantum Bioengineering, Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 423-day FDA review.

K002241 · Quantum Bioengineering, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2001
Decision
423d
Days
Class 2
Risk

K002241 is an FDA 510(k) clearance for the QUANTUM VERSATILITY (QVS) DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Quantum Bioengineering, Ltd. (Plantation, US). The FDA issued a Cleared decision on September 20, 2001 after a review of 423 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Quantum Bioengineering, Ltd. devices

FDA 510(k) Submission Details - K002241

510(k) Number K002241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 2000
Decision Date September 20, 2001
Days to Decision 423 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
296d slower than avg
Panel avg: 127d · This submission: 423d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DZE Device Classification - Class 2, Special Controls

Product Code DZE Implant, Endosseous, Root-form
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3640
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 869
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K002241.
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