Cleared Traditional

K941899 - SDI COMPOSTIES
(FDA 510(k) Clearance)

K941899 · Southern Dental Industries, Inc. · Dental

Jul 1994

Decision

77d

Days

Class 2

Risk

K941899 is an FDA 510(k) clearance for the SDI COMPOSTIES. This device is classified as a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF).

Submitted by Southern Dental Industries, Inc. (Pleasanton, US). The FDA issued a Cleared decision on July 5, 1994, 77 days after receiving the submission on April 19, 1994.

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

Submission Details

510(k) Number	K941899 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 19, 1994
Decision Date	July 05, 1994
Days to Decision	77 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement