Cleared Special

K122231 - XPEED ANY RIDGE INTERNAL IMPLANT SYSTEM

K122231 is an FDA 510(k) clearance for XPEED ANY RIDGE 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 70-day FDA review.

K122231 · Megagen Implant Co., Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2012
Decision
70d
Days
Class 2
Risk

K122231 is an FDA 510(k) clearance for the XPEED ANY RIDGE 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 October 4, 2012 after a review of 70 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Megagen Implant Co., Ltd. devices

FDA 510(k) Submission Details - K122231

510(k) Number K122231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 26, 2012
Decision Date October 04, 2012
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
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 1184
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K122231.
ENDOSSEOUS DENTAL IMPLANT
K113113 · Ot Medical GmbH · Nov 2012
MS SA IMPLANT SYSTEM
K122171 · Osstem Implant Co., Ltd. · Nov 2012
HERO II DENTAL IMPLANT SYSTEM, IS DENTAL IMPLANT SYSTEM
K121047 · Kj Meditech Co., Ltd. · Oct 2012
LEW MDI O-BALL COLLARED IMPLANT,
K121707 · Park Dental Research Corp. · Sep 2012
B&W DENTAL IMPLANT SYSTEM
K120875 · B&W Srl · Sep 2012
NEOSS PROACTIVE TAPERED IMPLANT
K113376 · Neoss, Ltd. · Sep 2012