Cleared Special

K123870 - XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM

K123870 is an FDA 510(k) clearance for XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM, manufactured by Megagen Implant Co., Ltd.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 100-day FDA review.

K123870 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
100d
Days
Class 2
Risk

K123870 is an FDA 510(k) clearance for the XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Megagen Implant Co., Ltd. (Brea, US). The FDA issued a Cleared decision on March 27, 2013 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3640 - the FDA dental device regulatory framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K123870

510(k) Number K123870 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 2012
Decision Date March 27, 2013
Days to Decision 100 days
Submission Type Special
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
28d faster than avg
Panel avg: 128d · This submission: 100d
Pathway characteristics
Modification to existing cleared device.

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 1547
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K123870 · XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
Download PDF FDA Summary Megagen Implant Co., …