Cleared Traditional

K092542 - M

K092542 is an FDA 510(k) clearance for M, manufactured by Mediscitec, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 247-day FDA review.

K092542 · Mediscitec, Inc. · Dental device
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Apr 2010
Decision
247d
Days
Class 2
Risk

K092542 is an FDA 510(k) clearance for the M. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Mediscitec, Inc. (Greenwood Village, US). The FDA issued a Cleared decision on April 23, 2010 after a review of 247 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Mediscitec, Inc. devices

FDA 510(k) Submission Details - K092542

510(k) Number K092542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 2009
Decision Date April 23, 2010
Days to Decision 247 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
120d slower than avg
Panel avg: 127d · This submission: 247d
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 924
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