Cleared Traditional

K002513 - ASTRA TECH IMPLANTS - DENTAL SYSTEM

K002513 is an FDA 510(k) clearance for ASTRA TECH IMPLANTS - DENTAL SYSTEM, manufactured by Astra Tech, Inc.. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 142-day FDA review.

K002513 · Astra Tech, Inc. · Dental device
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Jan 2001
Decision
142d
Days
Class 2
Risk

K002513 is an FDA 510(k) clearance for the ASTRA TECH IMPLANTS - DENTAL SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech, Inc. (Lexington, US). The FDA issued a Cleared decision on January 4, 2001 after a review of 142 days - within the typical 510(k) review window.

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 Astra Tech, Inc. devices

FDA 510(k) Submission Details - K002513

510(k) Number K002513 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2000
Decision Date January 04, 2001
Days to Decision 142 days
Submission Type Traditional
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
15d slower than avg
Panel avg: 127d · This submission: 142d
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 1011
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K002513.
ACE SDS 3.75MM SCREW DENTAL IMPLANT
K002075 · Ace Surgical Supply Co., Inc. · Feb 2001
OCO DENTAL IMPLANT
K010142 · "O" Co., Inc. · Feb 2001
THE LIFECORE STAGE-1 SINGLE STAGE RBM DENTAL IMPLANT SYSTEM
K003226 · Lifecore Biomedical, Inc. · Jan 2001
ADVENT IMPLANT SYSTEM
K002614 · Core-Vent Corp. · Dec 2000
REPLACE TPS COATED IMPLANTS
K002475 · Nobel Biocare Uas, Inc. · Nov 2000
ITI DENTAL IMPLANT SYSTEM MONOTYPE IMPLANT
K002374 · Straumann USA · Nov 2000