The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Conseal F.
| Device ID | K990650 |
| 510k Number | K990650 |
| Device Name: | CONSEAL F |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Product Code | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-01 |
| Decision Date | 1999-05-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3686200011 | K990650 | 000 |
| DO3686100011 | K990650 | 000 |
| DO3678500161 | K990650 | 000 |
| DO3678500131 | K990650 | 000 |
| DO3678500121 | K990650 | 000 |
| DO3678500081 | K990650 | 000 |
| DO3678500061 | K990650 | 000 |