Cleared Special

K042354 - MODIFICATION TO: CRESCO TI IMPLANT CONCEPT

K042354 is an FDA 510(k) clearance for MODIFICATION TO: CRESCO TI IMPLANT CONCEPT, manufactured by Cresco TI Systems AB. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 22-day FDA review.

K042354 · Cresco TI Systems AB · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2004
Decision
22d
Days
Class 2
Risk

K042354 is an FDA 510(k) clearance for the MODIFICATION TO: CRESCO TI IMPLANT CONCEPT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Cresco TI Systems AB (Kristianstad, SE). The FDA issued a Cleared decision on September 21, 2004 after a review of 22 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.

FDA 510(k) Submission Details - K042354

510(k) Number K042354 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2004
Decision Date September 21, 2004
Days to Decision 22 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
106d faster than avg
Panel avg: 128d · This submission: 22d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K042354.
FRIADENT PLUS DENTAL IMPLANT SYSTEMS
K040170 · Friadent GmbH · Oct 2004
MODIFICATION TO SILHOUETTE IC OR SILHOUETTE
K041136 · Bio-Lok Intl., Inc. · Oct 2004
STRYKER LEIBINGER SKELETAL ANCHORING SYSTEM
K041651 · Stryker Leibinger · Sep 2004
AMERICAN DENTAL IMPLANT
K042462 · American Dental Implant Corporation · Sep 2004
THE PRODIGY SYSTEM DENTAL IMPLANTS
K042429 · BioHorizons Implant Systems, Inc. · Sep 2004
MDI ORTHO
K042289 · Imtec Corp. · Sep 2004
K042354 · MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
Download PDF FDA Summary Cresco TI Systems AB