Cleared Abbreviated

SIC invent Dental Implant Systems (K173207) - FDA 510(k) Clearance

Class II Dental device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K173207 · Sic Invent AG · Dental device
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Apr 2018
Decision
185d
Days
Class 2
Risk

K173207 is an FDA 510(k) clearance for the SIC invent Dental Implant Systems. Classified as Implant, Endosseous, Root-form (product code DZE), Class II - Special Controls.

Submitted by Sic Invent AG (Basel, CH). The FDA issued a Cleared decision on April 5, 2018 after a review of 185 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Sic Invent AG devices

Submission Details

510(k) Number K173207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2017
Decision Date April 05, 2018
Days to Decision 185 days
Submission Type Abbreviated
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
58d slower than avg
Panel avg: 127d · This submission: 185d
Pathway characteristics
Standards-based clearance path.

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 304
Devices cleared under the same product code (DZE) and FDA review panel - the closest regulatory comparables to K173207.
OKTAGON Implant System
K180360 · Hager& Meisinger GmbH · May 2018
URIS OMNI System
K172100 · Truabutment, Inc. · May 2018
DTI-1 SLA IMPLANT SYSTEM
K170776 · Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi · Apr 2018
Kisses Plus Implant System
K172630 · Achimhai Medical Corporation · Apr 2018
UF(II) Implant System
K170608 · Dio Corporation · Mar 2018
Zygomatic Implant System
K173343 · Southern Implants (Pty), Ltd. · Feb 2018