Cleared Traditional

K073622 - EASY GRIP DENTAL IMPLANT SYSTEM

K073622 is an FDA 510(k) clearance for EASY GRIP DENTAL IMPLANT SYSTEM, manufactured by T.F.I. System S.R.L. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K073622 · T.F.I. System S.R.L · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
140d
Days
Class 2
Risk

K073622 is an FDA 510(k) clearance for the EASY GRIP DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by T.F.I. System S.R.L (Roma (Rm), IT). The FDA issued a Cleared decision on May 14, 2008 after a review of 140 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.

FDA 510(k) Submission Details - K073622

510(k) Number K073622 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 26, 2007
Decision Date May 14, 2008
Days to Decision 140 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
12d slower than avg
Panel avg: 128d · This submission: 140d
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 K073622.
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
REACTIVE DENTAL IMPLANT SYSTEM
K080713 · Implant Direct, LLC · 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
OSSEOSPEED NARROW
K080396 · Astra Tech AB · Apr 2008
K073622 · EASY GRIP DENTAL IMPLANT SYSTEM
Download PDF FDA Summary T.F.I. System S.R.L