Cleared Traditional

K120438 - FLASH (DIFFERENT MATERIALS)

K120438 is an FDA 510(k) clearance for FLASH (DIFFERENT MATERIALS), manufactured by 3M Deutschland GmbH. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K120438 · 3M Deutschland GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
79d
Days
Class 2
Risk

K120438 is an FDA 510(k) clearance for the FLASH (DIFFERENT MATERIALS). Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Deutschland GmbH (Bavaria D-82228 Seefeld, DE). The FDA issued a Cleared decision on May 2, 2012 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Deutschland GmbH devices

FDA 510(k) Submission Details - K120438

510(k) Number K120438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2012
Decision Date May 02, 2012
Days to Decision 79 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
48d faster than avg
Panel avg: 127d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
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 - ELW Material, Impression

All 200
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K120438.
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