Cleared Traditional

K062519 - NEXUS 3 (FDA 510(k) Clearance)

K062519 · Kerr Corporation · Dental device

Oct 2006

Decision

52d

Days

Class 2

Risk

K062519 is an FDA 510(k) clearance for the NEXUS 3. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Kerr Corporation (Newport Beach, US). The FDA issued a Cleared decision on October 19, 2006, 52 days after receiving the submission on August 28, 2006.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K062519 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 28, 2006
Decision Date	October 19, 2006
Days to Decision	52 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF