Cleared Special

ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX (K080074) - FDA 510(k) Clearance

Class II Dental device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080074 · Ace Surgical Supply Co., Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
34d
Days
Class 2
Risk

K080074 is an FDA 510(k) clearance for the ACE SURIGICAL TRU-FIX IMPLANT SYSTEM, MODEL 454-180X-XX. 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 February 14, 2008 after a review of 34 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

Submission Details

510(k) Number K080074 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2008
Decision Date February 14, 2008
Days to Decision 34 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
93d faster than avg
Panel avg: 127d · This submission: 34d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 1542
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