Cleared Abbreviated

K062051 - SS SYSTEM

K062051 is the FDA 510(k) clearance for SS SYSTEM by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code DZE) cleared through the Abbreviated 510(k) pathway after a 105-day FDA review.

K062051 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Nov 2006
Decision
105d
Days
Class 2
Risk

K062051 is an FDA 510(k) clearance for the SS SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Dunwoody, US). The FDA issued a Cleared decision on November 1, 2006 after a review of 105 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K062051 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2006
Decision Date November 01, 2006
Days to Decision 105 days
Submission Type Abbreviated
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
22d faster than avg
Panel avg: 127d · This submission: 105d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 588
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K062051.
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K061410 · Zimmer Dental, Inc. · Sep 2006