Cleared Traditional

K040170 - FRIADENT PLUS DENTAL IMPLANT SYSTEMS

K040170 is an FDA 510(k) clearance for FRIADENT PLUS DENTAL IMPLANT SYSTEMS, manufactured by Friadent GmbH. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 275-day FDA review.

K040170 · Friadent GmbH · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2004
Decision
275d
Days
Class 2
Risk

K040170 is an FDA 510(k) clearance for the FRIADENT PLUS DENTAL IMPLANT SYSTEMS. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Friadent GmbH (Lake Forest, US). The FDA issued a Cleared decision on October 27, 2004 after a review of 275 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.

FDA 510(k) Submission Details - K040170

510(k) Number K040170 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 2004
Decision Date October 27, 2004
Days to Decision 275 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
147d slower than avg
Panel avg: 128d · This submission: 275d
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 1424
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K040170.
THE 5.0 X 6.0MM DENTAL IMPLANT
K042637 · Bicon, Inc. · Nov 2004
NEOPLANT IMPLANT SYSTEM
K042339 · Neobiotech Co., Ltd. · Nov 2004
STERNGOLD 3.25 ERA DENTAL IMPLANT SYSTEM
K041271 · Sterngold · 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
MODIFICATION TO: CRESCO TI IMPLANT CONCEPT
K042354 · Cresco TI Systems AB · Sep 2004