The following data is part of a premarket notification filed by Sdi Ltd. with the FDA for Set Pp.
| Device ID | K073043 |
| 510k Number | K073043 |
| Device Name: | SET PP |
| Classification | Cement, Dental |
| 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 | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-10-29 |
| Decision Date | 2007-12-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| DO3688100061 | K073043 | 000 |
| DO3688051021 | K073043 | 000 |
| DO3688051031 | K073043 | 000 |
| DO3688051041 | K073043 | 000 |
| DO3688051051 | K073043 | 000 |
| DO3688100021 | K073043 | 000 |
| DO3688100031 | K073043 | 000 |
| DO3688100041 | K073043 | 000 |
| DO3688100051 | K073043 | 000 |
| DO3688051011 | K073043 | 000 |