The following data is part of a premarket notification filed by Dentecon, Inc. with the FDA for Thermabond V.
| Device ID | K926378 |
| 510k Number | K926378 |
| Device Name: | THERMABOND V |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | DENTECON, INC. 1251 SOUTH LA CIENEGE BLVD. PO BOX 35539 Los Angeles, CA 90035 |
| Contact | Varouj Hacopian |
| Correspondent | Varouj Hacopian DENTECON, INC. 1251 SOUTH LA CIENEGE BLVD. PO BOX 35539 Los Angeles, CA 90035 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-22 |
| Decision Date | 1994-11-01 |