Cleared Traditional

K062931 - IMPLUS IMPLANT SYSTEM

K062931 is an FDA 510(k) clearance for IMPLUS IMPLANT SYSTEM, manufactured by Leader Italia S.R.L.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K062931 · Leader Italia S.R.L. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2007
Decision
426d
Days
Class 2
Risk

K062931 is an FDA 510(k) clearance for the IMPLUS IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Leader Italia S.R.L. (New York, US). The FDA issued a Cleared decision on November 28, 2007 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K062931

510(k) Number K062931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2006
Decision Date November 28, 2007
Days to Decision 426 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
298d slower than avg
Panel avg: 128d · This submission: 426d
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 1483
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K062931.
ENDURE IMPLANT, MODEL 5108, 5111, 5113, 5114
K072660 · Imtec Corp. · Dec 2007
LEGACY DENTAL IMPLANTS
K073033 · Implant Direct, LLC · Dec 2007
SPI SYSTEM DENTAL IMPLANTS
K072649 · Thommen Medical AG · Dec 2007
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K071161 · Southern Implants, Inc. · Nov 2007
SPI CONTACT PLATFORM O 4.0 MM
K072933 · Thommen Medical AG · Nov 2007
T.B.R. ZIRCONNECT
K070935 · Sudimplant SA · Nov 2007
K062931 · IMPLUS IMPLANT SYSTEM
Download PDF FDA Summary Leader Italia S.R.L.