The following data is part of a premarket notification filed by Nordiska Dental Ab with the FDA for Ana 2000 Non Gamma 2 Extra High Copper Dental Alloy.
| Device ID | K002808 |
| 510k Number | K002808 |
| Device Name: | ANA 2000 NON GAMMA 2 EXTRA HIGH COPPER 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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853383006998 | K002808 | 000 |
| 00853383006578 | K002808 | 000 |
| 00853383006554 | K002808 | 000 |
| 00853383006547 | K002808 | 000 |
| 00853383006523 | K002808 | 000 |
| 00853383006417 | K002808 | 000 |
| 00853383006073 | K002808 | 000 |
| 00853383006066 | K002808 | 000 |
| 00853383006059 | K002808 | 000 |
| 00853383006042 | K002808 | 000 |
| 00853383006585 | K002808 | 000 |
| 00853383006608 | K002808 | 000 |
| 00853383006615 | K002808 | 000 |
| 00853383006981 | K002808 | 000 |
| 00853383006844 | K002808 | 000 |
| 00853383006837 | K002808 | 000 |
| 00853383006806 | K002808 | 000 |
| 00853383006783 | K002808 | 000 |
| 00853383006660 | K002808 | 000 |
| 00853383006646 | K002808 | 000 |
| 00853383006639 | K002808 | 000 |
| 00853383006622 | K002808 | 000 |
| 00853383006035 | K002808 | 000 |