Cleared Traditional

K151169 - OsteoReady ZircoSeal Abutments

K151169 is the FDA 510(k) clearance for OsteoReady ZircoSeal Abutments by Osteoready, LLC. It is a Class 2 Dental device (product code NHA) cleared through the Traditional 510(k) pathway after a 160-day FDA review.

K151169 · Osteoready, LLC · Dental device
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Oct 2015
Decision
160d
Days
Class 2
Risk

K151169 is an FDA 510(k) clearance for the OsteoReady ZircoSeal Abutments. 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 Osteoready, LLC (Seattle, US). The FDA issued a Cleared decision on October 8, 2015 after a review of 160 days - an extended review cycle.

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

View all Osteoready, LLC devices

Submission Details

510(k) Number K151169 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 2015
Decision Date October 08, 2015
Days to Decision 160 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
33d slower than avg
Panel avg: 127d · This submission: 160d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 464
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K151169.
ATLANTIS Abutment for NobelActive 3.0
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K151621 · BioHorizons Implant Systems, Inc. · Jan 2016
Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System
K151798 · Prismatik Dentalcraft, Inc. · Nov 2015
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System
K151375 · Prismatik Dentalcraft, Inc. · Oct 2015
Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants
K143515 · Prismatik Dentalcraft, Inc. · Oct 2015
Zimmer Patient-Specific Abutment, Internal Hex, Titanium
K143505 · Zimmer Dental, Inc. · Jun 2015