Cleared Traditional

K121749 - VERACIA

K121749 is an FDA 510(k) clearance for VERACIA, manufactured by Shofu Dental Corporation. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K121749 · Shofu Dental Corporation · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2012
Decision
85d
Days
Class 2
Risk

K121749 is an FDA 510(k) clearance for the VERACIA. 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 September 7, 2012 after a review of 85 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

FDA 510(k) Submission Details - K121749

510(k) Number K121749 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 14, 2012
Decision Date September 07, 2012
Days to Decision 85 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
42d faster than avg
Panel avg: 127d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELM Device Classification - Class 2, Special Controls

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 27
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K121749.
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955 · Wright Health Group , Ltd. · Mar 2013
NEW STETIC ARTIFICIAL TEETH
K122925 · New Stetic · Feb 2013
PHYSIOSTAR NFC
K122852 · Candulor USA, Inc. · Dec 2012
MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
K120404 · Merz Dental GmbH · May 2012
SR PHONARES II
K120736 · Ivoclar Vivadent, AG · May 2012
VERACIA SA
K113426 · Shofu Dental Corporation · Feb 2012