The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Adhesive 1.
| Device ID | K050331 |
| 510k Number | K050331 |
| Device Name: | ADHESIVE 1 |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, INC. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-10 |
| Decision Date | 2005-03-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3681004011 | K050331 | 000 |
| DO3681004001 | K050331 | 000 |