Cleared Traditional

K080713 - REACTIVE DENTAL IMPLANT SYSTEM

K080713 is an FDA 510(k) clearance for REACTIVE DENTAL IMPLANT 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 64-day FDA review.

K080713 · Implant Direct, LLC · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
64d
Days
Class 2
Risk

K080713 is an FDA 510(k) clearance for the REACTIVE DENTAL IMPLANT 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 May 16, 2008 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K080713

510(k) Number K080713 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2008
Decision Date May 16, 2008
Days to Decision 64 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
64d faster than avg
Panel avg: 128d · This submission: 64d
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 1500
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K080713.
I-MINI DENTAL IMPLANT
K080115 · Oco Biomedical · May 2008
SECURE IMPLANT SYSTEM (2.5/3.0MM)
K080129 · Dio Department Dsi, Inc. · May 2008
DIO BIOTITE-H IMPLANT SYSTEM
K073070 · Dio Department Dsi, Inc. · May 2008
EASY GRIP DENTAL IMPLANT SYSTEM
K073622 · T.F.I. System S.R.L · May 2008
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
K080128 · Dio Department Dsi, Inc. · May 2008
OMNI-TIGHT
K072595 · Basic Dental Implant Systems, Inc. · May 2008
K080713 · REACTIVE DENTAL IMPLANT SYSTEM
Download PDF FDA Summary Implant Direct, LLC