Cleared Special

K072595 - OMNI-TIGHT

K072595 is an FDA 510(k) clearance for OMNI-TIGHT, manufactured by Basic Dental Implant Systems, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 238-day FDA review.

K072595 · Basic Dental Implant Systems, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2008
Decision
238d
Days
Class 2
Risk

K072595 is an FDA 510(k) clearance for the OMNI-TIGHT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Basic Dental Implant Systems, Inc. (Lakewood, US). The FDA issued a Cleared decision on May 9, 2008 after a review of 238 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K072595

510(k) Number K072595 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2007
Decision Date May 09, 2008
Days to Decision 238 days
Submission Type Special
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
110d slower than avg
Panel avg: 128d · This submission: 238d
Pathway characteristics
Modification to existing cleared device.

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 1499
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K072595.
REACTIVE DENTAL IMPLANT SYSTEM
K080713 · Implant Direct, LLC · 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
OSSEOSPEED NARROW
K080396 · Astra Tech AB · Apr 2008
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
K080162 · Mis Implants Technologies , Ltd. · Apr 2008
DIO IMPLANT SYSTEM
K070570 · Dio Department Dsi, Inc. · Apr 2008
K072595 · OMNI-TIGHT
Download PDF FDA Summary Basic Dental Implant …