The following data is part of a premarket notification filed by Parkell, Inc. with the FDA for Cz-s2000.
| Device ID | K060946 |
| 510k Number | K060946 |
| Device Name: | CZ-S2000 |
| Classification | Resin, Root Canal Filling |
| Applicant | PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Contact | Nelson J Gendusa |
| Correspondent | Nelson J Gendusa PARKELL, INC. 300 EXECUTIVE DR. Edgewood, NY 11717 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-06 |
| Decision Date | 2006-06-15 |
| Summary: | summary |