The following data is part of a premarket notification filed by American Dent-all, Inc. with the FDA for Flexicast Prime.
| Device ID | K011706 |
| 510k Number | K011706 |
| Device Name: | FLEXICAST PRIME |
| Classification | Alloy, Metal, Base |
| Applicant | AMERICAN DENT-ALL, INC. 5140 SAN FERNANDO RD. Glendale, CA 91204 |
| Contact | Vachakan H Khoie |
| Correspondent | Vachakan H Khoie AMERICAN DENT-ALL, INC. 5140 SAN FERNANDO RD. Glendale, CA 91204 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-04 |
| Decision Date | 2001-08-06 |