The following data is part of a premarket notification filed by Sdi Ltd. with the FDA for Ultracaps S.
| Device ID | K081273 |
| 510k Number | K081273 |
| Device Name: | ULTRACAPS S |
| Classification | Dental Amalgam |
| Applicant | SDI LTD. 5-9 BRUNSDON ST. Bayswater, Victoria, AU 3153 |
| Contact | Ray Cahill |
| Correspondent | Ray Cahill SDI LTD. 5-9 BRUNSDON ST. Bayswater, Victoria, AU 3153 |
| Product Code | OIV |
| Subsequent Product Code | EJJ |
| Subsequent Product Code | ELY |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-05-05 |
| Decision Date | 2008-07-10 |