CONSEAL F

Sealant, Pit And Fissure, And Conditioner

SOUTHERN DENTAL INDUSTRIES, INC.

The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Conseal F.

Pre-market Notification Details

Device IDK990650
510k NumberK990650
Device Name:CONSEAL F
ClassificationSealant, Pit And Fissure, And Conditioner
Applicant SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco,  CA  94105
ContactSamantha J Cheetham
CorrespondentSamantha J Cheetham
SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco,  CA  94105
Product CodeEBC  
CFR Regulation Number872.3765 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-03-01
Decision Date1999-05-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
DO3686200011 K990650 000
DO3686100011 K990650 000
DO3678500161 K990650 000
DO3678500131 K990650 000
DO3678500121 K990650 000
DO3678500081 K990650 000
DO3678500061 K990650 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.