Cleared Traditional

K111185 - RELYX LUTING PLUS AUTOMIX

K111185 is an FDA 510(k) clearance for RELYX LUTING PLUS AUTOMIX, manufactured by 3M Espe Dental Products. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K111185 · 3M Espe Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
8d
Days
Class 2
Risk

K111185 is an FDA 510(k) clearance for the RELYX LUTING PLUS AUTOMIX. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by 3M Espe Dental Products (St. Paul, US). The FDA issued a Cleared decision on May 5, 2011 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Espe Dental Products devices

FDA 510(k) Submission Details - K111185

510(k) Number K111185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 2011
Decision Date May 05, 2011
Days to Decision 8 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
120d faster than avg
Panel avg: 128d · This submission: 8d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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

Intertek Testing Services
BERNARDO MEDELLIN J.D.

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 - EMA Cement, Dental

All 448
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K111185.
IP TEMP CEMENT
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TI-CORE FLOW
K101504 · Essential Dental Systems, Inc. · Oct 2010