The following data is part of a premarket notification filed by Rhein 83 Srl with the FDA for Modification Of: Sphero Flex, Pivot Flex, And Sphero Block.
| Device ID | K033630 |
| 510k Number | K033630 |
| Device Name: | MODIFICATION OF: SPHERO FLEX, PIVOT FLEX, AND SPHERO BLOCK |
| Classification | Implant, Endosseous, Root-form |
| Applicant | RHEIN 83 SRL 132 MONROE ST. Hoboken, NJ 07030 |
| Contact | Joseph E Grasso |
| Correspondent | Joseph E Grasso RHEIN 83 SRL 132 MONROE ST. Hoboken, NJ 07030 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-17 |
| Decision Date | 2004-04-21 |