The following data is part of a premarket notification filed by Temrex Corp. with the FDA for Hoffmann's Cement (phosphate, Normal).
| Device ID | K123273 |
| 510k Number | K123273 |
| Device Name: | HOFFMANN'S CEMENT (PHOSPHATE, NORMAL) |
| Classification | Cement, Dental |
| Applicant | TEMREX CORP. 300 Buffalo Ave Freeport, NY 11520 |
| Contact | Habib Lafir |
| Correspondent | Habib Lafir TEMREX CORP. 300 Buffalo Ave Freeport, NY 11520 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-19 |
| Decision Date | 2012-12-07 |