Cleared Traditional

K953191 - MODEL A15-101
(FDA 510(k) Clearance)

K953191 · Beaverstate Dental, Inc. · Dental device

Sep 1995

Decision

74d

Days

Class 1

Risk

K953191 is an FDA 510(k) clearance for the MODEL A15-101. This device is classified as a Light, Fiber Optic, Dental (Class I - General Controls, product code EAY).

Submitted by Beaverstate Dental, Inc. (Tualatin, US). The FDA issued a Cleared decision on September 5, 1995, 74 days after receiving the submission on June 23, 1995.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4620.

Submission Details

510(k) Number	K953191 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1995
Decision Date	September 05, 1995
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement