Cleared Special

K042429 - THE PRODIGY SYSTEM DENTAL IMPLANTS

K042429 is an FDA 510(k) clearance for THE PRODIGY SYSTEM DENTAL IMPLANTS, manufactured by BioHorizons Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 8-day FDA review.

K042429 · BioHorizons Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
8d
Days
Class 2
Risk

K042429 is an FDA 510(k) clearance for the THE PRODIGY SYSTEM DENTAL IMPLANTS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by BioHorizons Implant Systems, Inc. (Birmingham, US). The FDA issued a Cleared decision on September 16, 2004 after a review of 8 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 BioHorizons Implant Systems, Inc. devices

FDA 510(k) Submission Details - K042429

510(k) Number K042429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 2004
Decision Date September 16, 2004
Days to Decision 8 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
119d faster than avg
Panel avg: 127d · This submission: 8d
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 1179
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K042429.
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
K041651 · Stryker Leibinger · Sep 2004
MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
K042354 · Cresco TI Systems AB · Sep 2004
AMERICAN DENTAL IMPLANT
K042462 · American Dental Implant Corporation · Sep 2004
MDI ORTHO
K042289 · Imtec Corp. · Sep 2004
BIO PLANT SYSTEM (IMPLANTS AND ABUTMENTS)
K041655 · Cowellmedi Co., Ltd. · Sep 2004
ANKYLOS DENTAL IMPLANT SYSTEM
K041509 · Friadent GmbH · Aug 2004