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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
10d faster than avg
Panel avg: 128d · 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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K092674.
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
K093518 · Ace Surgical Supply Co., Inc. · Jan 2010
CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000
K091182 · Champions Implants GmbH · Jan 2010
UNO NARROW IMPLANT
K092555 · Mis Implants Technologies , Ltd. · Jan 2010
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
BOLLARD MINIPLATE SKELETAL ANCHORAGE SYSTEM
K091051 · Tita-Link · Dec 2009
HG III FIXTURE SYSTEM
K093352 · Hiossen, Inc. · Nov 2009
K092674 · SIMPLER TOADSTOOL MINI IMPLANT
Download PDF FDA Summary Pan Global Implant