Cleared Special

K021244 - ACE HA SCREW DENTAL IMPLANT SYSTEM

K021244 is an FDA 510(k) clearance for ACE HA SCREW DENTAL IMPLANT SYSTEM, 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 14-day FDA review.

K021244 · Ace Surgical Supply Co., Inc. · Dental device
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May 2002
Decision
14d
Days
Class 2
Risk

K021244 is an FDA 510(k) clearance for the ACE HA SCREW DENTAL IMPLANT SYSTEM. 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 May 3, 2002 after a review of 14 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 - K021244

510(k) Number K021244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2002
Decision Date May 03, 2002
Days to Decision 14 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 127d · This submission: 14d
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 789
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K021244.
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