Cleared Traditional

K120414 - OSSEOSPEED PLUS

K120414 is an FDA 510(k) clearance for OSSEOSPEED PLUS, 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 172-day FDA review.

K120414 · Astra Tech AB · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
172d
Days
Class 2
Risk

K120414 is an FDA 510(k) clearance for the OSSEOSPEED PLUS. 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 July 31, 2012 after a review of 172 days - an extended review 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: 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 - K120414

510(k) Number K120414 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2012
Decision Date July 31, 2012
Days to Decision 172 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
45d slower than avg
Panel avg: 127d · This submission: 172d
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 699
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K120414.
BIOHORIZONS TAPERED INTERNAL PLUS IMPLANTS
K121787 · BioHorizons Implant Systems, Inc. · Sep 2012
ZIMMER DENTAL TAPERED SCREW-VENT X
K113753 · Zimmer Dental, Inc. · Aug 2012
ET/SS IMPLANT SYSTEM
K120847 · Osstem Implant Co., Ltd. · Aug 2012
BL, 04.1 MM RC, SLACTIVE 8MM, TIZR AND 10MM, 12, 14MM
K121131 · Straumann USA · Jun 2012
HAPTITE COATING IMPLANT SYSTEM
K111364 · Dentis Co., Ltd. · Feb 2012
TAPERED SCREW-VENT X IMPLANT
K112160 · Zimmer Dental, Inc. · Dec 2011