Cleared Traditional

K925629 - ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT
(FDA 510(k) Clearance)

K925629 · Den-Tal-Ez Mfg Co., Inc. · Dental device

Nov 1993

Decision

382d

Days

Class 1

Risk

K925629 is an FDA 510(k) clearance for the ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).

Submitted by Den-Tal-Ez Mfg Co., Inc. (Lancaster, US). The FDA issued a Cleared decision on November 23, 1993, 382 days after receiving the submission on November 6, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.

Submission Details

510(k) Number	K925629 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 06, 1992
Decision Date	November 23, 1993
Days to Decision	382 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF