Cleared Traditional

3.0 Dynamic TiBase (K162021) - FDA 510(k) Clearance

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

K162021 · Talladium Espana, SL · Dental device
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May 2018
Decision
652d
Days
Class 2
Risk

K162021 is an FDA 510(k) clearance for the 3.0 Dynamic TiBase. 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 Talladium Espana, SL (Lleida, ES). The FDA issued a Cleared decision on May 4, 2018 after a review of 652 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

View all Talladium Espana, SL devices

Submission Details

510(k) Number K162021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date May 04, 2018
Days to Decision 652 days
Submission Type Traditional
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
525d slower than avg
Panel avg: 127d · This submission: 652d
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

Luiz Galdino
Luiz Galdino

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 K162021.
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
Neodent Implant System – GM Line
K173902 · Jjgc Industria E Comercio DE Materiais Dentarios S.A. · Apr 2018
OT EQUATOR
K171409 · Rhein 83 Srl · Apr 2018
Straumann Variobase for Crown AS
K173379 · Institut Straumann AG · Mar 2018