The following data is part of a premarket notification filed by Coltene/whaledent Inc. with the FDA for Coltosol F.
| Device ID | K031752 |
| 510k Number | K031752 |
| Device Name: | COLTOSOL F |
| Classification | Cement, Dental |
| Applicant | COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Contact | H.j. Vogelstein |
| Correspondent | H.j. Vogelstein COLTENE/WHALEDENT INC. 235 ASCOT PARKWAY Cuyahoga Falls, OH 44223 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-05 |
| Decision Date | 2003-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| J00659460 | K031752 | 000 |
| J00659350 | K031752 | 000 |
| J00659300 | K031752 | 000 |
| J00659160 | K031752 | 000 |
| J0065930US0 | K031752 | 000 |
| J00659110 | K031752 | 000 |
| J00659060 | K031752 | 000 |