Cleared Traditional

K120011 - HEISENBERG EFFECT SHADES

K120011 is an FDA 510(k) clearance for HEISENBERG EFFECT SHADES, manufactured by 3M Espe AG. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 10-day FDA review.

K120011 · 3M Espe AG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
10d
Days
Class 2
Risk

K120011 is an FDA 510(k) clearance for the HEISENBERG EFFECT SHADES. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by 3M Espe AG (Seefeld, DE). The FDA issued a Cleared decision on January 13, 2012 after a review of 10 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6660 - 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 3M Espe AG devices

FDA 510(k) Submission Details - K120011

510(k) Number K120011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2012
Decision Date January 13, 2012
Days to Decision 10 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 127d · This submission: 10d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EIH Device Classification - Class 2, Special Controls

Product Code EIH Powder, Porcelain
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6660
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 - EIH Powder, Porcelain

All 291
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K120011.
ZIRPRIME
K121980 · Kuraray Noritake Dental, Inc. · Oct 2012
IPS 99 ONE AND IPS 99 CERAM
K121359 · Ivoclar Vivadent, AG · Jul 2012
IPS E.MAX PRESS MULTI
K120134 · Ivoclar Vivadent, AG · Jun 2012
CERCON HT
K112152 · Dentsply International, Inc. · Nov 2011
ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR
K112710 · Wieland Dental + Technik GmbH & Co. KG · Oct 2011
IPS E.MAX CAD CRYSTALL / CONNECT AND IPS E.MAX CAD CRYSTAL / ADD-ON CONNECT (FOR CAD-ON TECHNIQUE)
K103556 · Ivoclar Vivadent, Inc. · Apr 2011