Cleared Traditional

PHYSIOSTAR NFC

K122852 · Candulor USA, Inc. · Dental

Dec 2012

Decision

79d

Days

Class 2

Risk

About This 510(k) Submission

K122852 is an FDA 510(k) clearance for the PHYSIOSTAR NFC, a Denture, Plastic, Teeth (Class II — Special Controls, product code ELM), submitted by Candulor USA, Inc. (Amherst, US). The FDA issued a Cleared decision on December 6, 2012, 79 days after receiving the submission on September 18, 2012. This device falls under the Dental review panel. Regulated under 21 CFR 872.3590.

Submission Details

510(k) Number	K122852 FDA.gov
FDA Decision	Cleared 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