Cleared Traditional

DESS Dental Smart Solutions (K191986) - FDA 510(k) Clearance

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

K191986 · Terrats Medical SL · Dental device
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Nov 2019
Decision
108d
Days
Class 2
Risk

K191986 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 November 10, 2019 after a review of 108 days - within the typical 510(k) review window.

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 K191986 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2019
Decision Date November 10, 2019
Days to Decision 108 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
19d faster than avg
Panel avg: 127d · This submission: 108d
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
Floyd G. Larson

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 K191986.
TSV BellaTek Express and BellaTek Flex Abutments
K192522 · Biomet 3i, LLC · Dec 2019
Neodent Implant System - Temporary Abutments
K191191 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Dec 2019
Southern Implants PEEK Abutments
K191250 · Southern Implants (Pty), Ltd. · Dec 2019
Scan Abutments and Comfort Caps
K191634 · Dentium Co., Ltd. · Nov 2019
Straumann PUREloc abutments
K192029 · Institut Straumann AG · Oct 2019
Legacy SMARTBase Abutments
K191458 · Implant Direct Sybron Manufacturing, LLC · Oct 2019