Cleared Special

K021460 - OCO DENTAL IMPLANT

K021460 is an FDA 510(k) clearance for OCO DENTAL IMPLANT, manufactured by "O" Co., Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 15-day FDA review.

K021460 · "O" Co., Inc. · Dental device
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May 2002
Decision
15d
Days
Class 2
Risk

K021460 is an FDA 510(k) clearance for the OCO DENTAL IMPLANT. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by "O" Co., Inc. (Albuquerque, US). The FDA issued a Cleared decision on May 22, 2002 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 - K021460

510(k) Number K021460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2002
Decision Date May 22, 2002
Days to Decision 15 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
112d faster than avg
Panel avg: 127d · This submission: 15d
Pathway characteristics
Modification to existing cleared device.

NHA Device Classification - Class 2, Special Controls

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 - NHA Abutment, Implant, Dental, Endosseous

All 561
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K021460.
SPI EASY DENTAL IMPLANT ABUTMENT
K023645 · Thommen Medical AG · Nov 2002
ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS
K023631 · Astra Tech, Inc. · Nov 2002
MODIFICATION TO THE MAESTRO SYSTEM
K022795 · BioHorizons Implant Systems, Inc. · Aug 2002
PROCERA PREPARABLE ABUTMENT SYSTEM
K974150 · Nobel Biocare Uas, Inc. · Jan 1998
AURADAPT AUBTMENT SYSTEM
K972475 · Nobel Biocare Uas, Inc. · Sep 1997
TIADAPT ABUTMENT SYSTEM
K971706 · Nobel Biocare Uas, Inc. · Jul 1997