Cleared Traditional

K122852 - PHYSIOSTAR NFC

K122852 is an FDA 510(k) clearance for PHYSIOSTAR NFC, manufactured by Candulor USA, Inc.. The device is a Class 2 Dental device with product code ELM cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K122852 · Candulor USA, Inc. · Dental device
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Dec 2012
Decision
79d
Days
Class 2
Risk

K122852 is an FDA 510(k) clearance for the PHYSIOSTAR NFC. Classified as Denture, Plastic, Teeth (product code ELM), Class II - Special Controls.

Submitted by Candulor USA, Inc. (Amherst, US). The FDA issued a Cleared decision on December 6, 2012 after a review of 79 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 Candulor USA, Inc. devices

FDA 510(k) Submission Details - K122852

510(k) Number K122852 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 18, 2012
Decision Date December 06, 2012
Days to Decision 79 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 127d · This submission: 79d
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 20
Devices cleared under the same product code (ELM) and FDA review panel - the closest regulatory comparables to K122852.
SR VIVODENT S, SR ORTHOTYP S, SR ORTHOLINGUAL S
K132984 · Ivoclar Vivadent, Inc. · Jan 2014
VERACIA
K121749 · Shofu Dental Corporation · Sep 2012
SR PHONARES II
K120736 · Ivoclar Vivadent, AG · May 2012
VERACIA SA
K113426 · Shofu Dental Corporation · Feb 2012
SR PHONARES NHC
K093331 · Ivoclar Vivadent, Inc. · Jan 2010
MONDIAL
K060994 · Heraeus Kulzer, Inc. · May 2006