Cleared Traditional

K033392 - IMMEDIATE STABILIZING IMPLANT (ISI)

K033392 is an FDA 510(k) clearance for IMMEDIATE STABILIZING IMPLANT (ISI), manufactured by "O" Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K033392 · "O" Co., Inc. · Dental device
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Dec 2003
Decision
48d
Days
Class 2
Risk

K033392 is an FDA 510(k) clearance for the IMMEDIATE STABILIZING IMPLANT (ISI). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by "O" Co., Inc. (Albuquerque, US). The FDA issued a Cleared decision on December 10, 2003 after a review of 48 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all "O" Co., Inc. devices

FDA 510(k) Submission Details - K033392

510(k) Number K033392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 2003
Decision Date December 10, 2003
Days to Decision 48 days
Submission Type Traditional
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
79d faster than avg
Panel avg: 127d · This submission: 48d
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 865
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K033392.
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3I TG OSSEOTITE IMPLANT, MODELS TG685, TG610, TG611, TG613, TG5685, TG5610, TG5611, TG5613, TG5615
K033430 · Implant Innovations, Inc. · Nov 2003
THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT
K032351 · BioHorizons Implant Systems, Inc. · Oct 2003