Cleared Traditional

K012496 - CARBON POST
(FDA 510(k) Clearance)

K012496 · J. Morita USA, Inc. · Dental device

May 2002

Decision

287d

Days

Class 1

Risk

K012496 is an FDA 510(k) clearance for the CARBON POST. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by J. Morita USA, Inc. (Washington, US). The FDA issued a Cleared decision on May 17, 2002, 287 days after receiving the submission on August 3, 2001.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.

Submission Details

510(k) Number	K012496 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 2001
Decision Date	May 17, 2002
Days to Decision	287 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement