Cleared Special

K070022 - MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 (FDA 510(k) Clearance)

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K070022 · Mis Implants Technologies , Ltd. · Dental device
Apr 2007
Decision
107d
Days
Class 2
Risk

K070022 is an FDA 510(k) clearance for the MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mis Implants Technologies , Ltd. (Elmwood Park, US). The FDA issued a Cleared decision on April 20, 2007 after a review of 107 days - within the typical 510(k) review window.

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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

Submission Details

510(k) Number K070022 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2007
Decision Date April 20, 2007
Days to Decision 107 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 158d · This submission: 107d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 69
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K070022.
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