Cleared Traditional

K081419 - STRAUMANN DENTAL IMPLANT SYSTEM

K081419 is the FDA 510(k) clearance for STRAUMANN DENTAL IMPLANT SYSTEM by Institut Straumann AG. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 276-day FDA review.

K081419 · Institut Straumann AG · Dental device
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Optimized for regulatory review, auditing and printing
Feb 2009
Decision
276d
Days
Class 2
Risk

K081419 is an FDA 510(k) clearance for the STRAUMANN DENTAL IMPLANT SYSTEM. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Institut Straumann AG (Andover, US). The FDA issued a Cleared decision on February 20, 2009 after a review of 276 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 Institut Straumann AG devices

Submission Details

510(k) Number K081419 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2008
Decision Date February 20, 2009
Days to Decision 276 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
149d slower than avg
Panel avg: 127d · This submission: 276d
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 581
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K081419.
HS II SHORT FIXTURE SYSTEM
K083633 · Osstem Implant Co., Ltd. · May 2009
I-FIX SYSTEM
K083586 · Dentis Co., Ltd. · Apr 2009
STRAUMANN DENTAL IMPLANT SYSTEM
K083550 · Straumann USA · Feb 2009
NOBELACTIVE 8.5 MM & 18.0 MM
K083205 · Nobel Biocare AB · Feb 2009
MS SYSTEM
K083067 · Osstem Implant Co., Ltd. · Feb 2009
ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
K082639 · Zimmer Dental, Inc. · Dec 2008