Cleared Traditional

K822411 - SYSTEM 80 FACEPLATE-IN-THE-EAR #F1
(FDA 510(k) Clearance)

K822411 · Western Advanced Technology, Inc. · Dental device

Jul 1983

Decision

336d

Days

Class 1

Risk

K822411 is an FDA 510(k) clearance for the SYSTEM 80 FACEPLATE-IN-THE-EAR #F1. This device is classified as a Syringe, Irrigating (dental) (Class I - General Controls, product code EIB).

Submitted by Western Advanced Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 12, 1983, 336 days after receiving the submission on August 10, 1982.

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

Submission Details

510(k) Number	K822411 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 10, 1982
Decision Date	July 12, 1983
Days to Decision	336 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—