Cleared Special

K092594 - ACE SURGICAL SECURE- MINI LOCATOR IMPLA...

K092594 is an FDA 510(k) clearance for ACE SURGICAL SECURE- MINI LOCATOR IMPLA..., manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 23-day FDA review.

K092594 · Ace Surgical Supply Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
23d
Days
Class 2
Risk

K092594 is an FDA 510(k) clearance for the ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-O.... Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ace Surgical Supply Co., Inc. (Brockton, US). The FDA issued a Cleared decision on September 16, 2009 after a review of 23 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. 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K092594

510(k) Number K092594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2009
Decision Date September 16, 2009
Days to Decision 23 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
104d faster than avg
Panel avg: 127d · This submission: 23d
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 788
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K092594.
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM
K093518 · Ace Surgical Supply Co., Inc. · Jan 2010
3.25 SPLINE TWIST IMPLANT, HA COATED
K093164 · Zimmer Dental, Inc. · Dec 2009
HG III FIXTURE SYSTEM
K093352 · Hiossen, Inc. · Nov 2009
SPI DENTAL IMPLANT INICELL
K090154 · Thommen Medical AG · Jul 2009
MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM
K082843 · Dentis Co., Ltd. · Jun 2009
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009