Cleared Traditional

K070570 - DIO IMPLANT SYSTEM

K070570 is an FDA 510(k) clearance for DIO IMPLANT SYSTEM, manufactured by Dio Department Dsi, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 412-day FDA review.

K070570 · Dio Department Dsi, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
412d
Days
Class 2
Risk

K070570 is an FDA 510(k) clearance for the DIO IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dio Department Dsi, Inc. (Santa Fe Springs, US). The FDA issued a Cleared decision on April 15, 2008 after a review of 412 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K070570

510(k) Number K070570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2007
Decision Date April 15, 2008
Days to Decision 412 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
284d slower than avg
Panel avg: 128d · This submission: 412d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K070570.
OMNI-TIGHT
K072595 · Basic Dental Implant Systems, Inc. · May 2008
OSSEOSPEED NARROW
K080396 · Astra Tech AB · Apr 2008
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
K080162 · Mis Implants Technologies , Ltd. · Apr 2008
RESCUE INTERNAL IMPLANT SYSTEM
K073058 · Megagen Co., Ltd. · Apr 2008
DIO PROTEM IMPLANT SYSTEM
K080126 · Dio Department Dsi, Inc. · Apr 2008
US/GS ULTRA WIDE SYSTEM
K073465 · Osstem Implant Co., Ltd. · Apr 2008
K070570 · DIO IMPLANT SYSTEM
Download PDF FDA Summary Dio Department Dsi, I…