Cleared Traditional

K990650 - CONSEAL F
(FDA 510(k) Clearance)

K990650 · Southern Dental Industries, Inc. · Dental

May 1999

Decision

74d

Days

Class 2

Risk

K990650 is an FDA 510(k) clearance for the CONSEAL F. This device is classified as a Sealant, Pit And Fissure, And Conditioner (Class II — Special Controls, product code EBC).

Submitted by Southern Dental Industries, Inc. (San Francisco, US). The FDA issued a Cleared decision on May 14, 1999, 74 days after receiving the submission on March 1, 1999.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3765.

Submission Details

510(k) Number	K990650 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 01, 1999
Decision Date	May 14, 1999
Days to Decision	74 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement