Cleared Traditional

K162021 - 3.0 Dynamic TiBase (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
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
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 Peers - NHA Abutment, Implant, Dental, Endosseous

All 701
Devices cleared under the same product code (NHA) and FDA review panel - the closest regulatory comparables to K162021.
DESS Dental Smart Solutions
K253804 · Terrats Medical SL · Apr 2026
LOCATOR® Angled Abutment
K260555 · Zest Anchors, LLC · Apr 2026
Healing Abutment System
K251434 · Osstem Implant Co., Ltd. · Mar 2026
Solidex® Ti-Links and Screws
K251515 · CreoDent Hudson Valley · Feb 2026
Multi-Unit DAS System
K243732 · Talladium Espa?a, SL · Jan 2026
EK MULTI ANGLED 30 ABUTMENT
K251427 · Hiossen, Inc. · Jan 2026