Cleared Abbreviated

K100902 - AEDIS(TM)

K100902 is an FDA 510(k) clearance for AEDIS(TM), manufactured by Embed Technology, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Abbreviated 510(k) pathway after a 84-day FDA review.

K100902 · Embed Technology, LLC · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2010
Decision
84d
Days
Class 2
Risk

K100902 is an FDA 510(k) clearance for the AEDIS(TM). Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Embed Technology, LLC (Chicago, US). The FDA issued a Cleared decision on June 24, 2010 after a review of 84 days - a notably fast clearance 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 Embed Technology, LLC devices

FDA 510(k) Submission Details - K100902

510(k) Number K100902 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 01, 2010
Decision Date June 24, 2010
Days to Decision 84 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 127d · This submission: 84d
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 922
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K100902.
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
MODIFICATION TO: HG III ULTRA WIDE SYSTEM
K093889 · Hiossen, Inc. · Apr 2010
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM
K093321 · BioHorizons Implant Systems, Inc. · Apr 2010
SPI DENTAL IMPLANT, ELEMENT
K093615 · Thommen Medical AG · Mar 2010