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) Official FDA 510(k) Summary (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.

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 128d · 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 Consultant

Tuv Sud America, Inc.
NORBERT STUIBER

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 - EIH Powder, Porcelain

All 472
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