The following data is part of a premarket notification filed by Satelec with the FDA for Biosplint Splinting Ribbon.
| Device ID | K053328 |
| 510k Number | K053328 |
| Device Name: | BIOSPLINT SPLINTING RIBBON |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SATELEC 130 GAITHER DRIVE SUITE 100 Mt. Laurel, NJ 08054 |
| Contact | Steven Salesky |
| Correspondent | Steven Salesky SATELEC 130 GAITHER DRIVE SUITE 100 Mt. Laurel, NJ 08054 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-01 |
| Decision Date | 2006-01-25 |
| Summary: | summary |