Cleared Traditional

K061319 - SPECTRA SYSTEM

K061319 is an FDA 510(k) clearance for SPECTRA SYSTEM, manufactured by Implant Direct, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K061319 · Implant Direct, LLC · Dental device
Download Printable Device Report (PDF)
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Sep 2006
Decision
141d
Days
Class 2
Risk

K061319 is an FDA 510(k) clearance for the SPECTRA SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Implant Direct, LLC (Calabasas, US). The FDA issued a Cleared decision on September 29, 2006 after a review of 141 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 Implant Direct, LLC devices

FDA 510(k) Submission Details - K061319

510(k) Number K061319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2006
Decision Date September 29, 2006
Days to Decision 141 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d slower than avg
Panel avg: 127d · This submission: 141d
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 934
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K061319.
SS SYSTEM
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K062129 · Institut Straumann AG · Oct 2006
SUPER ORTHODONTIC SCREW
K062156 · Osstem Implant Co., Ltd. · Oct 2006
SCREW-VENT IMPLANT SYSTEM, SV
K061410 · Zimmer Dental, Inc. · Sep 2006
ZIMMER ONE-PIECE IMPLANT, 3.7 MM, ANGLED
K061717 · Zimmer Dental, Inc. · Sep 2006
ZIMMER ONE-PIECE IMPLANT, 4.7MM, STRAIGHT, MODELS ZOP47S10, ZOP47S11, ZOP47S13, ZOP47S16
K062281 · Zimmer Dental, Inc. · Sep 2006