Cleared Traditional

K973091 - WAVE
(FDA 510(k) Clearance)

K973091 · Southern Dental Industries, Inc. · Dental device

Dec 1997

Decision

112d

Days

Class 2

Risk

K973091 is an FDA 510(k) clearance for the WAVE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on December 8, 1997, 112 days after receiving the submission on August 18, 1997.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K973091 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 18, 1997
Decision Date	December 08, 1997
Days to Decision	112 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement