The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Cls-2000 Unit.
| Device ID | K024133 |
| 510k Number | K024133 |
| Device Name: | CLS-2000 UNIT |
| Classification | Sterilizer, Steam |
| Applicant | DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Contact | P. Jeffery Lehn |
| Correspondent | P. Jeffery Lehn DENTSPLY INTL. 570 WEST COLLEGE AVE. York, PA 17405 -0872 |
| Product Code | FLE |
| CFR Regulation Number | 880.6880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-16 |
| Decision Date | 2003-10-01 |
| Summary: | summary |