The following data is part of a premarket notification filed by L.c. Dental with the FDA for Ana 70 Dispersed Phase Dental Alloy -- Modified.
| Device ID | K923384 |
| 510k Number | K923384 |
| Device Name: | ANA 70 DISPERSED PHASE DENTAL ALLOY -- MODIFIED |
| Classification | Alloy, Amalgam |
| Applicant | L.C. DENTAL 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer L.C. DENTAL 1819 SO. MAY ST. UNIT 2F Chicago, IL 60608 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-28 |
| Decision Date | 1993-01-11 |