The following data is part of a premarket notification filed by Scientific Pharmaceuticals, Inc. with the FDA for Fastfil.
| Device ID | K934184 |
| 510k Number | K934184 |
| Device Name: | FASTFIL |
| Classification | Cement, Dental |
| Applicant | SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Contact | Jan A Orlowski |
| Correspondent | Jan A Orlowski SCIENTIFIC PHARMACEUTICALS, INC. 3221 PRODUCER WAY Pomona, CA 91768 -3916 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-27 |
| Decision Date | 1993-12-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816526021258 | K934184 | 000 |
| D801SP55601B1 | K934184 | 000 |
| D801SP55601BS1 | K934184 | 000 |
| D801SP55601BSN1 | K934184 | 000 |
| D801SP55602T1 | K934184 | 000 |
| 00850015110351 | K934184 | 000 |
| 00850015110368 | K934184 | 000 |
| 00816526021234 | K934184 | 000 |
| 00816526021241 | K934184 | 000 |
| D801SP556011 | K934184 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() FASTFIL 76171835 not registered Dead/Abandoned |
ANALYTICAL SENSORS, INC. 2000-11-28 |
![]() FASTFIL 75179831 2097740 Live/Registered |
SCIENTIFIC PHARMACEUTICALS, INC. 1996-10-10 |