Cleared Traditional

K113426 - VERACIA SA

K113426 is the FDA 510(k) clearance for VERACIA SA by Shofu Dental Corporation. It is a Class 2 Dental device (product code ELM) cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K113426 · Shofu Dental Corporation · Dental device
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Feb 2012
Decision
82d
Days
Class 2
Risk

K113426 is an FDA 510(k) clearance for the VERACIA SA. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on February 8, 2012 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - 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 Shofu Dental Corporation devices

Submission Details

510(k) Number K113426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2011
Decision Date February 08, 2012
Days to Decision 82 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 127d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELM Denture, Plastic, Teeth
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3590
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 - ELM Denture, Plastic, Teeth

All 14
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K113426.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
VERACIA
K121749 · Shofu Dental Corporation · Sep 2012
SR PHONARES NHC
K093331 · Ivoclar Vivadent, Inc. · Jan 2010
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006
CONDYLAFORM II NFC
K060565 · Ivoclar Vivadent, Inc. · May 2006
ARTIC
K033628 · Heraeus Kulzer, Inc. · Jan 2004