The following data is part of a premarket notification filed by Tokuyama America, Inc. with the FDA for Bistite Ii Dc.
| Device ID | K011685 |
| 510k Number | K011685 |
| Device Name: | BISTITE II DC |
| Classification | Cement, Dental |
| Applicant | TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Contact | Daniel J Manelli |
| Correspondent | Daniel J Manelli TOKUYAMA AMERICA, INC. 2000 M ST. NW SUITE 700 Washington, DC 20036 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-31 |
| Decision Date | 2001-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04548190165476 | K011685 | 000 |
| 04548190163076 | K011685 | 000 |
| 04548190163083 | K011685 | 000 |
| 04548190163113 | K011685 | 000 |
| 04548190163120 | K011685 | 000 |
| 04548190163137 | K011685 | 000 |
| 04548190163366 | K011685 | 000 |
| 04548190163373 | K011685 | 000 |
| 04548190163380 | K011685 | 000 |
| 04548190163717 | K011685 | 000 |
| 04548190165438 | K011685 | 000 |
| 04548190163069 | K011685 | 000 |