Cleared Traditional

K012156 - IMAGINE H.E.

K012156 is an FDA 510(k) clearance for IMAGINE H.E., manufactured by Wieland Edelmetalle GmbH & Co.. The device is a Class 2 Dental device with product code EIH cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K012156 · Wieland Edelmetalle GmbH & Co. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
36d
Days
Class 2
Risk

K012156 is an FDA 510(k) clearance for the IMAGINE H.E.. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Wieland Edelmetalle GmbH & Co. (Pforzheim, DE). The FDA issued a Cleared decision on August 16, 2001 after a review of 36 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 - K012156

510(k) Number K012156 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 2001
Decision Date August 16, 2001
Days to Decision 36 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 128d · This submission: 36d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 487
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K012156.
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K011428 · Dentaurum, Inc. · Jun 2001
K012156 · IMAGINE H.E.
Download PDF FDA Summary Wieland Edelmetalle G…