Cleared Special

K120847 - ET/SS IMPLANT SYSTEM

K120847 is an FDA 510(k) clearance for ET/SS IMPLANT SYSTEM, manufactured by Osstem Implant Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 143-day FDA review.

K120847 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
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Aug 2012
Decision
143d
Days
Class 2
Risk

K120847 is an FDA 510(k) clearance for the ET/SS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Fariless Hills, US). The FDA issued a Cleared decision on August 10, 2012 after a review of 143 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Osstem Implant Co., Ltd. devices

FDA 510(k) Submission Details - K120847

510(k) Number K120847 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2012
Decision Date August 10, 2012
Days to Decision 143 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
16d slower than avg
Panel avg: 127d · This submission: 143d
Pathway characteristics
Modification to existing cleared device.

DZE Device Classification - Class 2, Special Controls

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 1095
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