The following data is part of a premarket notification filed by Coltene, Inc. with the FDA for Coltosol Temporary Endodontic Filling Material.
| Device ID | K902392 |
| 510k Number | K902392 |
| Device Name: | COLTOSOL TEMPORARY ENDODONTIC FILLING MATERIAL |
| Classification | Cement, Dental |
| Applicant | COLTENE, INC. 168 NO. MICHIGAN AVE. STE. 800 Chicago, IL 60601 |
| Contact | Bauer, Phd |
| Correspondent | Bauer, Phd COLTENE, INC. 168 NO. MICHIGAN AVE. STE. 800 Chicago, IL 60601 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-05-30 |
| Decision Date | 1990-08-28 |