Cleared Traditional

K921354 - BLUNT TIP IRRIGATION NEEDLES
(FDA 510(k) Clearance)

K921354 · Innovators, Inc. · Dental device

Sep 1992

Decision

189d

Days

Class 1

Risk

K921354 is an FDA 510(k) clearance for the BLUNT TIP IRRIGATION NEEDLES. This device is classified as a Burnisher, Operative (Class I - General Controls, product code EKJ).

Submitted by Innovators, Inc. (Jefferson City, US). The FDA issued a Cleared decision on September 25, 1992, 189 days after receiving the submission on March 20, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K921354 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 20, 1992
Decision Date	September 25, 1992
Days to Decision	189 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement