Cleared Special

K102981 - ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM

K102981 is an FDA 510(k) clearance for ACE FREEDOM INTERNAL HEXAGON DENTAL IMP..., manufactured by Ace Surgical Supply Company, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Special 510(k) pathway after a 74-day FDA review.

K102981 · Ace Surgical Supply Company, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2010
Decision
74d
Days
Class 2
Risk

K102981 is an FDA 510(k) clearance for the ACE FREEDOM INTERNAL HEXAGON DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Ace Surgical Supply Company, Inc. (Brockton, US). The FDA issued a Cleared decision on December 20, 2010 after a review of 74 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 Company, Inc. devices

FDA 510(k) Submission Details - K102981

510(k) Number K102981 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2010
Decision Date December 20, 2010
Days to Decision 74 days
Submission Type Special
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 127d · This submission: 74d
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 895
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K102981.
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GC AADVA IMPLANT SYSTEM
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SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS
K102308 · Dentium Co., Ltd. · Nov 2010