Cleared Traditional

K031326 - IMAGINE REFLEX

K031326 is the FDA 510(k) clearance for IMAGINE REFLEX by Wieland Dental + Technik GmbH & Co. KG. It is a Class 2 Dental device (product code EIH) cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K031326 · Wieland Dental + Technik GmbH & Co. KG · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
53d
Days
Class 2
Risk

K031326 is an FDA 510(k) clearance for the IMAGINE REFLEX. Classified as Powder, Porcelain (product code EIH), Class II - Special Controls.

Submitted by Wieland Dental + Technik GmbH & Co. KG (Pforzheim, DE). The FDA issued a Cleared decision on June 17, 2003 after a review of 53 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 Wieland Dental + Technik GmbH & Co. KG devices

Submission Details

510(k) Number K031326 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 2003
Decision Date June 17, 2003
Days to Decision 53 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 127d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 227
Devices cleared under the same product code (EIH) and FDA review panel - the closest regulatory comparables to K031326.
CARRARA PRESS SYSTEM
K033667 · Dentsply Intl. · Jan 2004
PFZ PORCELAIN SYSTEM
K033553 · Dentsply Intl. · Dec 2003
VINTAGE AL
K032165 · Shofu Dental Corp. · Sep 2003
CERCON CERAM S PORCELAIN
K022796 · Dentsply Intl. · Sep 2002
ERIS LAYERING MATERIALS
K012174 · Ivoclar North America, Inc. · Aug 2001
AVANTE MICRO CRYSTAL SYSTEM
K012231 · Jeneric/Pentron, Inc. · Aug 2001