Cleared Traditional

K120951 - SMARTBUILDER SYSTEM

K120951 is the FDA 510(k) clearance for SMARTBUILDER SYSTEM by Osstem Implant Co., Ltd.. It is a Class 2 Dental device (product code JEY) cleared through the Traditional 510(k) pathway after a 187-day FDA review.

K120951 · Osstem Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
187d
Days
Class 2
Risk

K120951 is an FDA 510(k) clearance for the SMARTBUILDER SYSTEM. Classified as Plate, Bone (product code JEY), Class II - Special Controls.

Submitted by Osstem Implant Co., Ltd. (Fariless Hills, US). The FDA issued a Cleared decision on October 3, 2012 after a review of 187 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4760 - 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 Osstem Implant Co., Ltd. devices

Submission Details

510(k) Number K120951 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 2012
Decision Date October 03, 2012
Days to Decision 187 days
Submission Type Traditional
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
60d slower than avg
Panel avg: 127d · This submission: 187d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code JEY Plate, Bone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4760
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 - JEY Plate, Bone

All 146
Devices cleared under the same product code (JEY) and FDA review panel - the closest regulatory comparables to K120951.
SMARTBUILDER SYSTEM (SB1)
K130840 · Osstem Implant Co., Ltd. · Sep 2013
STRYKER UNIVERSAL ORBITAL FLOOR SYSTEM
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K122313 · Stryker · Oct 2012
ARTISAN SPACE MAINTENANCE SYSTEM
K120271 · Medtronic Sofamor Danek USA, Inc. · May 2012
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K112064 · KLS-Martin L.P. · Mar 2012
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K110259 · Medtronic Sofamor Danek USA, Inc. · Apr 2011