The following data is part of a premarket notification filed by Bisco, Inc. with the FDA for Therabase, Therabase Ca.
| Device ID | K192007 |
| 510k Number | K192007 |
| Device Name: | TheraBase, TheraBase Ca |
| Classification | Cement, Dental |
| Applicant | Bisco, Inc. 1100 West Irving Park Rd. Schaumburg, IL 60193 |
| Contact | Diana Vu |
| Correspondent | Diana Vu Bisco, Inc. 1100 West Irving Park Rd. Schaumburg, IL 60193 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-29 |
| Decision Date | 2020-03-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D757H3502S0 | K192007 | 000 |
| 00810111541367 | K192007 | 000 |
| 00810111541381 | K192007 | 000 |
| 00810111541398 | K192007 | 000 |
| 00810111541404 | K192007 | 000 |
| 00810111541350 | K192007 | 000 |
| 00810111541374 | K192007 | 000 |
| 00810111541411 | K192007 | 000 |
| D757H35000 | K192007 | 000 |
| D757H35001P1 | K192007 | 000 |
| D757H35010 | K192007 | 000 |
| D757H35010P1 | K192007 | 000 |
| D757H3501PS1 | K192007 | 000 |
| D757H3501S0 | K192007 | 000 |
| D757H3502PS1 | K192007 | 000 |
| 00810111541343 | K192007 | 000 |