Cleared Traditional

K091239 - ASTRA TECH IMPLANT SYSTEM

K091239 is an FDA 510(k) clearance for ASTRA TECH IMPLANT SYSTEM, manufactured by Astra Tech AB. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 148-day FDA review.

K091239 · Astra Tech AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
148d
Days
Class 2
Risk

K091239 is an FDA 510(k) clearance for the ASTRA TECH IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Astra Tech AB (San Diego, US). The FDA issued a Cleared decision on September 22, 2009 after a review of 148 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 AB devices

FDA 510(k) Submission Details - K091239

510(k) Number K091239 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2009
Decision Date September 22, 2009
Days to Decision 148 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
21d slower than avg
Panel avg: 127d · This submission: 148d
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 1322
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K091239.
BEGO SEMADOS S-LINE
K090716 · Bego Implant Systems GmbH & Co. KG · Oct 2009
OSSEOLINK DENTAL IMPLANT SYSTEM
K091878 · Global Implant Solutions, LLC · Oct 2009
BTI DENTAL IMPLANT TINY 2.5-3.0
K092112 · B.T.I. Biotechnology Institute, Sl. · Oct 2009
ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX
K092594 · Ace Surgical Supply Co., Inc. · Sep 2009
TSI
K090174 · Oco Biomedical · Sep 2009
SINUS QUICK EB SYSTEM
K090377 · Neobiotech Co., Ltd. · Aug 2009