Cleared Special

K070022 - MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9

K070022 is an FDA 510(k) clearance for MISTRAL - ONE STAGE SCREW-TYPE DENTAL I..., manufactured by Mis Implants Technologies , Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 107-day FDA review.

K070022 · Mis Implants Technologies , Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K070022

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 128d · This submission: 107d
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 1546
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K070022 · MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9
Download PDF FDA Summary Mis Implants Technolo…