Cleared Traditional

K161987 - UF(II) Narrow Implant System - Fixture

K161987 is an FDA 510(k) clearance for UF(II) Narrow Implant System - Fixture, manufactured by Dio Corporation. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 217-day FDA review.

K161987 · Dio Corporation · Dental device
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Feb 2017
Decision
217d
Days
Class 2
Risk

K161987 is an FDA 510(k) clearance for the UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Supras.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dio Corporation (Busan, KR). The FDA issued a Cleared decision on February 21, 2017 after a review of 217 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 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 Dio Corporation devices

FDA 510(k) Submission Details - K161987

510(k) Number K161987 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2016
Decision Date February 21, 2017
Days to Decision 217 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
90d slower than avg
Panel avg: 127d · This submission: 217d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 759
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K161987.
TSIII BA Fixture
K163088 · Osstem Implant Co., Ltd. · Apr 2017
NobelZygoma 0°
K161598 · Nobel Biocare AB · Mar 2017
BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment
K162890 · Straumann USA, LLC · Mar 2017
US SA Implant System
K161103 · Osstem Implant Co., Ltd. · Feb 2017
s-Clean OneQ-SL Narrow Implant System
K161244 · Dentis Co., Ltd. · Dec 2016
ETIII SA Fixture System (O3.2mm)
K153332 · Hiossen, Inc. · Oct 2016