The following data is part of a premarket notification filed by Metalor Dental Usa Corp. with the FDA for Pagalin 2.
| Device ID | K911675 |
| 510k Number | K911675 |
| Device Name: | PAGALIN 2 |
| Classification | Alloy, Other Noble Metal |
| Applicant | METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
| Contact | Brian Schiller |
| Correspondent | Brian Schiller METALOR DENTAL USA CORP. 457 LAUREL RD. BOX 369 Rockville Centre, NY 11571 -0369 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-04-11 |
| Decision Date | 1991-06-27 |