Cleared Traditional

K080396 - OSSEOSPEED NARROW

K080396 is an FDA 510(k) clearance for OSSEOSPEED NARROW, 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 77-day FDA review.

K080396 · Astra Tech AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2008
Decision
77d
Days
Class 2
Risk

K080396 is an FDA 510(k) clearance for the OSSEOSPEED NARROW. 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 April 30, 2008 after a review of 77 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Astra Tech AB devices

FDA 510(k) Submission Details - K080396

510(k) Number K080396 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2008
Decision Date April 30, 2008
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
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 K080396.
EASY GRIP DENTAL IMPLANT SYSTEM
K073622 · T.F.I. System S.R.L · May 2008
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM
K080128 · Dio Department Dsi, Inc. · May 2008
OMNI-TIGHT
K072595 · Basic Dental Implant Systems, Inc. · May 2008
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT
K080162 · Mis Implants Technologies , Ltd. · Apr 2008
DIO IMPLANT SYSTEM
K070570 · Dio Department Dsi, Inc. · Apr 2008
RESCUE INTERNAL IMPLANT SYSTEM
K073058 · Megagen Co., Ltd. · Apr 2008