The following data is part of a premarket notification filed by Polydentia Usa with the FDA for Fiber-splint Ml Multilayer.
| Device ID | K962374 |
| 510k Number | K962374 |
| Device Name: | FIBER-SPLINT ML MULTILAYER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | POLYDENTIA USA 1819 SO. MAY ST. 2F Chicago, IL 60608 |
| Contact | Robert W Bauer |
| Correspondent | Robert W Bauer POLYDENTIA USA 1819 SO. MAY ST. 2F Chicago, IL 60608 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-20 |
| Decision Date | 1996-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| E29965251 | K962374 | 000 |
| E29959710 | K962374 | 000 |
| E29959720 | K962374 | 000 |
| E29959730 | K962374 | 000 |
| E29959731 | K962374 | 000 |
| E29959740 | K962374 | 000 |
| E29959741 | K962374 | 000 |
| E29959760 | K962374 | 000 |
| E29959770 | K962374 | 000 |
| E29959790 | K962374 | 000 |
| E29959800 | K962374 | 000 |
| E29965250 | K962374 | 000 |
| E29959700 | K962374 | 000 |