Cleared Traditional

K053384 - FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM

K053384 is an FDA 510(k) clearance for FIXATURE MICROTHREAD OSSEOSPEED, 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 109-day FDA review.

K053384 · Astra Tech, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2006
Decision
109d
Days
Class 2
Risk

K053384 is an FDA 510(k) clearance for the FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech, Inc. (San Diego, US). The FDA issued a Cleared decision on March 24, 2006 after a review of 109 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.

FDA 510(k) Submission Details - K053384

510(k) Number K053384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2005
Decision Date March 24, 2006
Days to Decision 109 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
19d faster than avg
Panel avg: 128d · This submission: 109d
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 1528
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K053384.
INTERMEZZO PLUS FIXTURE
K053354 · Megagen Co., Ltd. · Apr 2006
OSTEOMED ORTHODONTIC ANCHOR PLATING SYSTEM
K051798 · Osteomed LP · Apr 2006
ENDOSSEOUS DENTAL IMPLANT SYSTEM
K053478 · Northern Implants, LLC · Apr 2006
A.B. DENTAL DEVICES
K051719 · A.B. Dental Devices , Ltd. · Mar 2006
BTI INTERNA DENTAL IMPLANT SYSTEM
K053355 · B.T.I. Biotechnology Institute, Sl. · Mar 2006
LEONE IMPLANT SYSTEM
K050586 · Leone S.P.A. · Feb 2006
K053384 · FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM
Download PDF FDA Summary Astra Tech, Inc.