Cleared Traditional

K052840 - IGI-SYSTEM

K052840 is an FDA 510(k) clearance for IGI-SYSTEM, manufactured by Denx Advanced Dental Systems. The device is a Class 2 Neurology device with product code HAW cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K052840 · Denx Advanced Dental Systems · Neurology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2005
Decision
70d
Days
Class 2
Risk

K052840 is an FDA 510(k) clearance for the IGI-SYSTEM. Classified as Neurological Stereotaxic Instrument (product code HAW), Class II - Special Controls.

Submitted by Denx Advanced Dental Systems (Jerusalem, Al, IL). The FDA issued a Cleared decision on December 16, 2005 after a review of 70 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4560 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K052840

510(k) Number K052840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2005
Decision Date December 16, 2005
Days to Decision 70 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 149d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

HAW Device Classification - Class 2, Special Controls

Product Code HAW Neurological Stereotaxic Instrument
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4560
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 Neurology devices follow this clearance model.

Regulatory Consultant

Kema Quality B.V.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - HAW Neurological Stereotaxic Instrument

All 418
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K052840 · IGI-SYSTEM
Download PDF FDA Summary Denx Advanced Dental …