Cleared Traditional

K100100 - DIO STEADY EXTERNAL IMPLANT SYSTEM

K100100 is an FDA 510(k) clearance for DIO STEADY EXTERNAL IMPLANT SYSTEM, 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 302-day FDA review.

K100100 · Dio Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
302d
Days
Class 2
Risk

K100100 is an FDA 510(k) clearance for the DIO STEADY EXTERNAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Dio Corporation (Los Angeles, US). The FDA issued a Cleared decision on November 10, 2010 after a review of 302 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: Standard predicate-based submission. Elevated predicate reliance profile. 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 - K100100

510(k) Number K100100 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 2010
Decision Date November 10, 2010
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
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 K100100.
INCLUSIVE MINI IMPLANT
K100932 · Prismatik Dentalcraft, Inc. · Dec 2010
NOBEL ACTIVE 3.0
K102436 · Nobel Biocare AB · Dec 2010
GC AADVA IMPLANT SYSTEM
K093749 · GC America, Inc. · Dec 2010
HT III SA FIXTURE SYSTEM
K101096 · Hiossen, Inc. · Oct 2010
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT
K101880 · Zimmer Dental, Inc. · Oct 2010
TAPERED SCREW-VENT T IMPLANT
K101977 · Zimmer Dental, Inc. · Sep 2010