The following data is part of a premarket notification filed by Rapid Injection Systems Corp. with the FDA for Flexite Supreme, Flexite Plus, Flexite M.p., Northern And Flexite Pro-guard.
| Device ID | K072479 |
| 510k Number | K072479 |
| Device Name: | FLEXITE SUPREME, FLEXITE PLUS, FLEXITE M.P., NORTHERN AND FLEXITE PRO-GUARD |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | RAPID INJECTION SYSTEMS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 |
| Contact | Sol Soroca |
| Correspondent | Sol Soroca RAPID INJECTION SYSTEMS CORP. 30 NORTHPORT RD. Sound Beach, NY 11789 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-04 |
| Decision Date | 2007-11-09 |