Cleared Traditional

K123386 - PERIOTYPE X-PERT

K123386 is an FDA 510(k) clearance for PERIOTYPE X-PERT, manufactured by Clinical House Europe GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K123386 · Clinical House Europe GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
175d
Days
Class 2
Risk

K123386 is an FDA 510(k) clearance for the PERIOTYPE X-PERT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Clinical House Europe GmbH (Las Vegas, US). The FDA issued a Cleared decision on April 26, 2013 after a review of 175 days - an extended review cycle.

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. Standard predicate reliance. 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 Clinical House Europe GmbH devices

FDA 510(k) Submission Details - K123386

510(k) Number K123386 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2012
Decision Date April 26, 2013
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
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 838
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K123386.
ANYONETM INTERNAL IMPLANT SYSTEM
K123988 · Megagen Implant Co., Ltd. · Aug 2013
ETII SA FIXTURE SYSTEM
K123471 · Hiossen, Inc. · Jul 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K130222 · Straumann USA, LLC · Apr 2013
STRAUMANN DENTAL IMPLANT SYSTEM
K123784 · Straumann USA, LLC · Apr 2013
XPEED ANYRIDGE INTERNAL IMPLANT SYSTEM
K123870 · Megagen Implant Co., Ltd. · Mar 2013
INCLUSIVE TAPERED IMPLANT SYSTEM
K121406 · Prismatik Dentalcraft, Inc. · Feb 2013