Cleared Abbreviated

K062030 - US SYSTEM

K062030 is the FDA 510(k) clearance for US 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 107-day FDA review.

K062030 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2006
Decision
107d
Days
Class 2
Risk

K062030 is an FDA 510(k) clearance for the US 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 2, 2006 after a review of 107 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 K062030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2006
Decision Date November 02, 2006
Days to Decision 107 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
20d faster than avg
Panel avg: 127d · This submission: 107d
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 K062030.
ZIMMER ONE PIECE IMPLANT, 3.7MM AND 4.7MM, MODELS ZOP37S10, 11, 13, 16
K063523 · Zimmer Dental, Inc. · Feb 2007
SFB AND CFB IMPLANTS - 5.0 PLATFORM
K063718 · Nobel Biocare AB · Jan 2007
NOBELPERFECT CONICAL CONNECTION
K062936 · Nobel Biocare AB · Dec 2006
SS SYSTEM
K062051 · Osstem Implant Co., Ltd. · Nov 2006
P.0004 IMPLANTS
K062129 · Institut Straumann AG · Oct 2006
SUPER ORTHODONTIC SCREW
K062156 · Osstem Implant Co., Ltd. · Oct 2006