The following data is part of a premarket notification filed by Star Refining Precious Metals South Africa with the FDA for Starbond Dental Bonding Alloys.
| Device ID | K032106 |
| 510k Number | K032106 |
| Device Name: | STARBOND DENTAL BONDING ALLOYS |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | STAR REFINING PRECIOUS METALS SOUTH AFRICA PO BOX 4341 Crofton, MD 21114 |
| Contact | Yolanda Smith |
| Correspondent | Ned E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-07-08 |
| Decision Date | 2003-08-25 |