Cleared Traditional

K171784 - Straumann Dental Implant System

K171784 is an FDA 510(k) clearance for Straumann Dental Implant System, 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 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

FDA 510(k) Submission Details - K171784

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.

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 1193
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
MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
K172505 · Mis Implants Technologies , Ltd. · Dec 2017
PREMIUM ONE Implant Systems
K172560 · Sweden & Martina S.P.A. · Dec 2017
S.I.N. Implant System
K170392 · S.I.N. ? Sistema DE Implante Nacional S.A. · Dec 2017