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 |