Cleared Traditional

K161987 - UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure

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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 128d · 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 Consultant

Dio USA
PETER KANG

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DZE Implant, Endosseous, Root-form

All 1369
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K161987.
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
Dental Implants OKTAGON Tissue Level and Bone Level
K162073 · Hager& Meisinger GmbH · Feb 2017
IBS Implant System II
K162099 · Innobiosurg Co., Ltd. · Feb 2017
US SA Implant System
K161103 · Osstem Implant Co., Ltd. · Feb 2017
GMI Frontier Dental Implant System
K161593 · Ilerimplant S.L · Jan 2017