Cleared Traditional

K110131 - LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROWN RESTORATIVE

K110131 is an FDA 510(k) clearance for LAVA ULTIMATE CAD/CAM RESTORATIVE FOR C..., manufactured by 3M Espe Dental Products. The device is a Class 2 Dental device with product code EBF cleared through the Traditional 510(k) pathway after a 3-day FDA review.

K110131 · 3M Espe Dental Products · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2011
Decision
3d
Days
Class 2
Risk

K110131 is an FDA 510(k) clearance for the LAVA ULTIMATE CAD/CAM RESTORATIVE FOR CEREC / E4D, LAVA ULTIMATE IMPLANT CROW.... Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by 3M Espe Dental Products (St. Paul, US). The FDA issued a Cleared decision on January 21, 2011 after a review of 3 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 - K110131

510(k) Number K110131 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date January 21, 2011
Days to Decision 3 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
125d faster than avg
Panel avg: 128d · This submission: 3d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

EBF Device Classification - Class 2, Special Controls

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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
GINGER CANTOR

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 - EBF Material, Tooth Shade, Resin

All 843
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K110131.
ESCOM 100
K110428 · Spident Co., Ltd. · Feb 2011
PROFIL COMPOSITES (PROFIL, PROFIL FLOW)
K103190 · Silmet , Ltd. · Feb 2011
GRANDIO SO FLOW
K103580 · Voco GmbH · Jan 2011
DMC COMPOSITE 2
K103351 · Kerr Corporation · Jan 2011
BUILD-IT TOTAL CORE
K102703 · Pentron Clinical · Jan 2011
AURA
K102984 · Sdi Limited · Dec 2010