The following data is part of a premarket notification filed by Nordiska Dental Ab with the FDA for Ana 3000 Sm Non Gamma 2 Modified Spherical Dental Alloy.
| Device ID | K002810 |
| 510k Number | K002810 |
| Device Name: | ANA 3000 SM NON GAMMA 2 MODIFIED SPHERICAL DENTAL ALLOY |
| Classification | Alloy, Amalgam |
| Applicant | NORDISKA DENTAL AB P.O. BOX 435 Lynwood, WA 98046 |
| Contact | Richard Kirschner |
| Correspondent | Richard Kirschner NORDISKA DENTAL AB P.O. BOX 435 Lynwood, WA 98046 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-09-08 |
| Decision Date | 2000-10-31 |