Cleared Abbreviated

K111162 - SLIM ONEBODY SYSTEM

K111162 is an FDA 510(k) clearance for SLIM ONEBODY SYSTEM, manufactured by Dentium Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 263-day FDA review.

K111162 · Dentium Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
263d
Days
Class 2
Risk

K111162 is an FDA 510(k) clearance for the SLIM ONEBODY SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dentium Co., Ltd. (Cypress, US). The FDA issued a Cleared decision on January 13, 2012 after a review of 263 days - an extended review cycle.

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 Dentium Co., Ltd. devices

FDA 510(k) Submission Details - K111162

510(k) Number K111162 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2011
Decision Date January 13, 2012
Days to Decision 263 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
136d slower than avg
Panel avg: 127d · This submission: 263d
Pathway characteristics
Standards-based clearance path.

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 793
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