Cleared Traditional

Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue (K181484) - FDA 510(k) Clearance

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

K181484 · Zirkonzahn Srl · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
13d
Days
Class 2
Risk

K181484 is an FDA 510(k) clearance for the Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Ti.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Zirkonzahn Srl (Gais, IT). The FDA issued a Cleared decision on June 18, 2018 after a review of 13 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Zirkonzahn Srl devices

Submission Details

510(k) Number K181484 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 05, 2018
Decision Date June 18, 2018
Days to Decision 13 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
114d faster than avg
Panel avg: 127d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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

Regulatory Technology Services, LLC
MARK JOB

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 - EBF Material, Tooth Shade, Resin

All 291
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K181484.
BRILLIANT Crios
K181500 · Coltene/Whaledent AG · Aug 2018
Estelite Universal Flow
K180613 · Tokuyama Dental Corporation · Jul 2018
Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit
K172952 · Figaro Crowns, Inc. · Jul 2018
BeautiCem Veneer Kit
K180649 · Shofu Dental Corporation · Jun 2018
Tetric CAD
K173573 · Ivoclar Vivadent, AG · Jun 2018
NMF004A
K173500 · GC America, Inc. · Mar 2018