Cleared Special

K023336 - OCO DENTAL IMPLANT (5.0MM DIAMETER)

K023336 is an FDA 510(k) clearance for OCO DENTAL IMPLANT (5.0MM DIAMETER), manufactured by "O" Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 2-day FDA review.

K023336 · "O" Co., Inc. · Dental device
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Oct 2002
Decision
2d
Days
Class 2
Risk

K023336 is an FDA 510(k) clearance for the OCO DENTAL IMPLANT (5.0MM DIAMETER). 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 October 9, 2002 after a review of 2 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all "O" Co., Inc. devices

FDA 510(k) Submission Details - K023336

510(k) Number K023336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2002
Decision Date October 09, 2002
Days to Decision 2 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 127d · This submission: 2d
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 866
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K023336.
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