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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 128d · 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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K100902.
DEFCON TSA/TSH DENTAL IMPLANT SYSTEM
K092261 · Impladent, S.L. · Jul 2010
SARGON NON-EXPANDABLE DENTAL IMPLANT
K082573 · Sargon Ent., Inc. · Jul 2010
COTEC DENTAL IMPLANT SYSTEM
K100511 · Cotec Implant Co., Ltd. · Jul 2010
BIODENTA DENTAL IMPLANT SYSTEM
K093630 · Biodenta Swiss AG · Jun 2010
ZIT-Z
K092507 · Ziterion · May 2010
M
K092542 · Mediscitec, Inc. · Apr 2010
K100902 · AEDIS(TM)
Download PDF FDA Summary Embed Technology, LLC