The following data is part of a premarket notification filed by Nats Corp. with the FDA for Dentorium Convertible Acrylic.
| Device ID | K011820 |
| 510k Number | K011820 |
| Device Name: | DENTORIUM CONVERTIBLE ACRYLIC |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Contact | Richard C Lanzillotto |
| Correspondent | Richard C Lanzillotto NATS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 -1734 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-06-11 |
| Decision Date | 2001-09-05 |