The following data is part of a premarket notification filed by Southern Dental Industries, Ltd. with the FDA for Set.
| Device ID | K051008 |
| 510k Number | K051008 |
| Device Name: | SET |
| Classification | Cement, Dental |
| Applicant | SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Contact | Ray Cahill |
| Correspondent | Ray Cahill SOUTHERN DENTAL INDUSTRIES, LTD. 729 N. ROUTE 83, SUITE 315 Bensenville, IL 60106 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2005-04-20 |
| Decision Date | 2005-06-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3688100001 | K051008 | 000 |
| DO3688050031 | K051008 | 000 |
| DO3688050021 | K051008 | 000 |
| DO3688050011 | K051008 | 000 |