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) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
15d slower than avg
Panel avg: 128d · 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 1532
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K120847.
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K113753 · Zimmer Dental, Inc. · Aug 2012
CONICAL CONNECTION IMPLANTS
K112162 · Mis Implants Technologies , Ltd. · Aug 2012
ET II BIO-SA FIXTURE SYSTEM
K112532 · Hiossen, Inc. · Aug 2012
OSSEOSPEED PLUS
K120414 · Astra Tech AB · Jul 2012
K120847 · ET/SS IMPLANT SYSTEM
Download PDF FDA Summary Osstem Implant Co., L…