The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Tescera Fiber Bundles, Fiber Mesh And Fiber Cylinders.
| Device ID | K034024 |
| 510k Number | K034024 |
| Device Name: | TESCERA FIBER BUNDLES, FIBER MESH AND FIBER CYLINDERS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Contact | Benjamin Lichtenwalner |
| Correspondent | Benjamin Lichtenwalner BISCO, INC. 1100 WEST IRVING PARK RD. Schaumburg, IL 60193 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-29 |
| Decision Date | 2004-03-19 |
| Summary: | summary |