Cleared Traditional

K002513 - ASTRA TECH IMPLANTS - DENTAL SYSTEM

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

K002513 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
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.

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 467
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K002513.
OSSEOTITE DENTAL IMPLANTS
K013570 · Implant Innovations, Inc. · Dec 2001
3I LOCATER ABUTMENT SYSTEM
K012911 · Implant Innovations, Inc. · Sep 2001
MODIFICATION TO ITI DENTAL IMPLANT SYSTEM
K003271 · Institut Straumann AG · Mar 2001
ENDOSSEOUS IMPLANTS AND ABUTMENTS- TIN COATING
K992334 · Implant Innovations, Inc. · Oct 1999
3I CERAMIC ABUTMENT SYSTEM
K991947 · Implant Innovations, Inc. · Sep 1999
ITI DENTAL IMPLANT SYSTEM
K983742 · Institut Straumann AG · Mar 1999