The following data is part of a premarket notification filed by Dentecon, Inc. with the FDA for Thermabond Supercast Np Or Thermabond Supercast.
| Device ID | K911821 |
| 510k Number | K911821 |
| Device Name: | THERMABOND SUPERCAST NP OR THERMABOND SUPERCAST |
| Classification | Alloy, Metal, Base |
| Applicant | DENTECON, INC. 1251 SOUTH LA CIENEGE BLVD. PO BOX 35539 Los Angeles, CA 90035 |
| Contact | John Yavrouian |
| Correspondent | John Yavrouian DENTECON, INC. 1251 SOUTH LA CIENEGE BLVD. PO BOX 35539 Los Angeles, CA 90035 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-24 |
| Decision Date | 1991-05-30 |