Cleared Traditional

K092674 - SIMPLER TOADSTOOL MINI IMPLANT

K092674 is an FDA 510(k) clearance for SIMPLER TOADSTOOL MINI IMPLANT, manufactured by Pan Global Implant. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K092674 · Pan Global Implant · Dental device
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Dec 2009
Decision
118d
Days
Class 2
Risk

K092674 is an FDA 510(k) clearance for the SIMPLER TOADSTOOL MINI IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Pan Global Implant (Vancouver, CA). The FDA issued a Cleared decision on December 28, 2009 after a review of 118 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. 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 Pan Global Implant devices

FDA 510(k) Submission Details - K092674

510(k) Number K092674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 01, 2009
Decision Date December 28, 2009
Days to Decision 118 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 127d · This submission: 118d
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
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K092674.
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K092594 · Ace Surgical Supply Co., Inc. · Sep 2009