Cleared Traditional

K002075 - ACE SDS 3.75MM SCREW DENTAL IMPLANT

K002075 is an FDA 510(k) clearance for ACE SDS 3.75MM SCREW DENTAL IMPLANT, manufactured by Ace Surgical Supply Co., Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 207-day FDA review.

K002075 · Ace Surgical Supply Co., Inc. · Dental device
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Feb 2001
Decision
207d
Days
Class 2
Risk

K002075 is an FDA 510(k) clearance for the ACE SDS 3.75MM SCREW DENTAL IMPLANT. 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 2, 2001 after a review of 207 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Ace Surgical Supply Co., Inc. devices

FDA 510(k) Submission Details - K002075

510(k) Number K002075 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 2000
Decision Date February 02, 2001
Days to Decision 207 days
Submission Type Traditional
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
80d slower than avg
Panel avg: 127d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 790
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K002075.
ITI DENTAL IMPLANT SYSTEM
K010291 · Straumann USA · May 2001
THE MAESTRO SYSTEM
K010458 · BioHorizons Implant Systems, Inc. · May 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001
ASTRA TECH IMPLANTS - DENTAL SYSTEM
K002513 · Astra Tech, Inc. · Jan 2001
ADVENT IMPLANT SYSTEM
K002614 · Core-Vent Corp. · Dec 2000