Cleared Abbreviated

K122955 - DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM

K122955 is an FDA 510(k) clearance for DENTAVIT, manufactured by Wright Health Group , Ltd.. The device is a Class 2 Dental device with product code ELM cleared through the Abbreviated 510(k) pathway after a 157-day FDA review.

K122955 · Wright Health Group , Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2013
Decision
157d
Days
Class 2
Risk

K122955 is an FDA 510(k) clearance for the DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Wright Health Group , Ltd. (Sound Beach, US). The FDA issued a Cleared decision on March 1, 2013 after a review of 157 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3590 - the FDA dental device regulatory framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Wright Health Group , Ltd. devices

FDA 510(k) Submission Details - K122955

510(k) Number K122955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2012
Decision Date March 01, 2013
Days to Decision 157 days
Submission Type Abbreviated
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
29d slower than avg
Panel avg: 128d · This submission: 157d
Pathway characteristics
Standards-based clearance path.

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 39
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K122955.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
NEW STETIC ARTIFICIAL TEETH
K122925 · New Stetic · Feb 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