The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Benco Spherical.
| Device ID | K031658 |
| 510k Number | K031658 |
| Device Name: | BENCO SPHERICAL |
| Classification | Alloy, Amalgam |
| 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 | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-28 |
| Decision Date | 2003-07-29 |