Cleared Special

K040714 - HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT

K040714 is an FDA 510(k) clearance for HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT, manufactured by Innova Corp.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 22-day FDA review.

K040714 · Innova Corp. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2004
Decision
22d
Days
Class 2
Risk

K040714 is an FDA 510(k) clearance for the HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Innova Corp. (Washington, US). The FDA issued a Cleared decision on April 9, 2004 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K040714

510(k) Number K040714 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2004
Decision Date April 09, 2004
Days to Decision 22 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 128d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040714.
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K034014 · Thommen Medical AG · Mar 2004
K040714 · HYBRID ENDOPORE ENDOSSEOUS DENTAL IMPLANT
Download PDF FDA Summary Innova Corp.