Cleared Traditional

K122925 - NEW STETIC ARTIFICIAL TEETH

K122925 is an FDA 510(k) clearance for NEW STETIC ARTIFICIAL TEETH, manufactured by New Stetic. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K122925 · New Stetic · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
141d
Days
Class 2
Risk

K122925 is an FDA 510(k) clearance for the NEW STETIC ARTIFICIAL TEETH. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by New Stetic (Apollo Beach, US). The FDA issued a Cleared decision on February 12, 2013 after a review of 141 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K122925

510(k) Number K122925 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2012
Decision Date February 12, 2013
Days to Decision 141 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
13d slower than avg
Panel avg: 128d · This submission: 141d
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 45
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K122925.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
K122955 · Wright Health Group , Ltd. · Mar 2013
PHYSIOSTAR NFC
K122852 · Candulor USA, Inc. · Dec 2012
VERACIA
K121749 · Shofu Dental Corporation · Sep 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