Cleared Traditional

K012849 - GLASS POST
(FDA 510(k) Clearance)

K012849 · J. Morita USA, Inc. · Dental device

Mar 2002

Decision

236d

Days

Class 1

Risk

K012849 is an FDA 510(k) clearance for the GLASS 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 March 27, 2002, 236 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	K012849 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 03, 2001
Decision Date	March 27, 2002
Days to Decision	236 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement