Cleared Traditional

K140878 - STRAUMANN BONE LEVEL TAPERED IMPLANT

K140878 is an FDA 510(k) clearance for STRAUMANN BONE LEVEL TAPERED IMPLANT, manufactured by Straumann USA, LLC. The device is a Class 2 Dental device with product code DZE cleared through the Traditional 510(k) pathway after a 135-day FDA review.

K140878 · Straumann USA, LLC · Dental device
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Aug 2014
Decision
135d
Days
Class 2
Risk

K140878 is an FDA 510(k) clearance for the STRAUMANN BONE LEVEL TAPERED IMPLANT. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Straumann USA, LLC (Andover, US). The FDA issued a Cleared decision on August 20, 2014 after a review of 135 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 Straumann USA, LLC devices

FDA 510(k) Submission Details - K140878

510(k) Number K140878 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2014
Decision Date August 20, 2014
Days to Decision 135 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
8d slower than avg
Panel avg: 127d · This submission: 135d
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 1236
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