Cleared Traditional

K884277 - AD POST (FDA 510(k) Clearance)

K884277 · J. Morita USA, Inc. · Dental device
Dec 1988
Decision
71d
Days
Class 1
Risk

K884277 is an FDA 510(k) clearance for the AD POST. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on December 22, 1988, 71 days after receiving the submission on October 12, 1988.

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

Submission Details

510(k) Number K884277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1988
Decision Date December 22, 1988
Days to Decision 71 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code ELR — Post, Root Canal
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.3810