Cleared Special

K061969 - PREFORMANCE POSTS AND TEMPORARY CYLINDERS

K061969 is an FDA 510(k) clearance for PREFORMANCE POSTS AND TEMPORARY CYLINDERS, manufactured by Implant Innovations, Inc.. The device is a Class 2 Dental device with product code NHA cleared through the Special 510(k) pathway after a 9-day FDA review.

K061969 · Implant Innovations, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
9d
Days
Class 2
Risk

K061969 is an FDA 510(k) clearance for the PREFORMANCE POSTS AND TEMPORARY CYLINDERS. 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 Implant Innovations, Inc. (Palm Beach Gardens, US). The FDA issued a Cleared decision on July 21, 2006 after a review of 9 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 Implant Innovations, Inc. devices

FDA 510(k) Submission Details - K061969

510(k) Number K061969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2006
Decision Date July 21, 2006
Days to Decision 9 days
Submission Type Special
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
118d faster than avg
Panel avg: 127d · This submission: 9d
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 533
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