Cleared Traditional

DESS Dental Smart Solutions (K173908) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K173908 · Terrats Medical SL · Dental device
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Optimized for regulatory review, auditing and printing
Jun 2018
Decision
175d
Days
Class 2
Risk

K173908 is an FDA 510(k) clearance for the DESS Dental Smart Solutions. Classified as Abutment, Implant, Dental, Endosseous within the NHA classification (a category for dental implant abutments and prosthetic components), Class II - Special Controls.

Submitted by Terrats Medical SL (Barberá Del Vallés, ES). The FDA issued a Cleared decision on June 15, 2018 after a review of 175 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3630 - 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 Terrats Medical SL devices

Submission Details

510(k) Number K173908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2017
Decision Date June 15, 2018
Days to Decision 175 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
48d slower than avg
Panel avg: 127d · This submission: 175d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NHA Abutment, Implant, Dental, Endosseous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3630
Definition To Be Used In Conjunction With An Endosseous Dental Implant Fixture To Aid In Prosthetic Rehabilitation.
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 Consultant

PaxMed International, LLC
Linda K. Schulz

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - NHA Abutment, Implant, Dental, Endosseous

All 318
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K173908.
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Straumann Variobase for Bridge/Bar Cylindrical
K173968 · Institut Straumann AG · Jul 2018
Rodo Smilekey
K180609 · Rodo Medical, Inc. · May 2018
ArgenIS Titanium Abutments
K172430 · Argen Corporation · May 2018
Dentium Implantium & SuperLine Prosthetics
K172640 · Dentium Co., Ltd. · May 2018