Cleared Traditional

K131404 - FLASH AR PENTA / FLASH AR PENTA QUICK

K131404 is an FDA 510(k) clearance for FLASH AR PENTA / FLASH AR PENTA QUICK, 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 15-day FDA review.

K131404 · 3M Deutschland GmbH · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
15d
Days
Class 2
Risk

K131404 is an FDA 510(k) clearance for the FLASH AR PENTA / FLASH AR PENTA QUICK. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by 3M Deutschland GmbH (Seefeld, DE). The FDA issued a Cleared decision on May 30, 2013 after a review of 15 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 - K131404

510(k) Number K131404 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 2013
Decision Date May 30, 2013
Days to Decision 15 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
113d faster than avg
Panel avg: 128d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
ALEXANDER SCHAPOVALOV

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 - ELW Material, Impression

All 342
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