The following data is part of a premarket notification filed by Zhermack Dental Production with the FDA for Elite Regular Body.
| Device ID | K935887 |
| 510k Number | K935887 |
| Device Name: | ELITE REGULAR BODY |
| Classification | Material, Impression |
| Applicant | ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
| Contact | Monica Martello |
| Correspondent | Monica Martello ZHERMACK DENTAL PRODUCTION VIA BOVAZECCHINO, 100 45021 BADIA POLESINE (rovigo) Italy, IT |
| Product Code | ELW |
| CFR Regulation Number | 872.3660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-12 |
| Decision Date | 1994-08-23 |