Cleared Traditional

K171784 - Straumann Dental Implant System

K171784 is the FDA 510(k) clearance for Straumann Dental Implant System by Straumann USA, LLC. It is a Class 2 Dental device (product code DZE) cleared through the Traditional 510(k) pathway after a 218-day FDA review.

K171784 · Straumann USA, LLC · Dental device
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Jan 2018
Decision
218d
Days
Class 2
Risk

K171784 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 Straumann USA, LLC (Andover, US). The FDA issued a Cleared decision on January 19, 2018 after a review of 218 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 Straumann USA, LLC devices

Submission Details

510(k) Number K171784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 2017
Decision Date January 19, 2018
Days to Decision 218 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
91d slower than avg
Panel avg: 127d · This submission: 218d
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 645
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K171784.
BR Type Implant System
K171179 · Biotem Co., Ltd. · Feb 2018
AR_N Type Implant System
K171297 · Biotem Co., Ltd. · Jan 2018
SPI Dental Implant System
K172240 · Msi France · Jan 2018
BioHorizons Tapered Short Implants
K172576 · BioHorizons Implant Systems, Inc. · Nov 2017
TREFOIL System
K172352 · Nobel Biocare AB · Oct 2017
Dentis Dental Implant System
K171027 · Dentis Co., Ltd. · Sep 2017