Cleared Traditional

K143353 - Hahn Tapered Implant System

K143353 is an FDA 510(k) clearance for Hahn Tapered Implant System, manufactured by Prismatik Dentalcraft, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K143353 · Prismatik Dentalcraft, Inc. · Dental device
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Apr 2015
Decision
129d
Days
Class 2
Risk

K143353 is an FDA 510(k) clearance for the Hahn Tapered Implant System. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Prismatik Dentalcraft, Inc. (Irvine, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 129 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. 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 Prismatik Dentalcraft, Inc. devices

FDA 510(k) Submission Details - K143353

510(k) Number K143353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 24, 2014
Decision Date April 02, 2015
Days to Decision 129 days
Submission Type Traditional
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
2d slower than avg
Panel avg: 127d · This submission: 129d
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 1015
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K143353.
MiNi Internal Implant System
K150537 · Megagen Implant Co., Ltd. · Jul 2015
2014 InterActive/SwishActive System
K143011 · Implant Direct Sybron Manufacturing, LLC · Jul 2015
NobelActive
K142260 · Nobel Biocare AB · May 2015
BioHorizons Tapered Internal Implants
K143022 · BioHorizons Implant Systems, Inc. · Jan 2015
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM
K140091 · Megagen Implant Co., Ltd. · Dec 2014
HIOSSEN IMPLANT SYSTEM
K140934 · Hiossen, Inc. · Nov 2014