The following data is part of a premarket notification filed by Kay See Dental Mfg. Co. with the FDA for Hydro-cast Versa-temp Non-eugenol Provisional Cement, Model 70010.
| Device ID | K990155 |
| 510k Number | K990155 |
| Device Name: | HYDRO-CAST VERSA-TEMP NON-EUGENOL PROVISIONAL CEMENT, MODEL 70010 |
| Classification | Cement, Dental |
| Applicant | KAY SEE DENTAL MFG. CO. 124 EAST MISSOURI AVE. Kansas City, MO 64106 -1294 |
| Contact | Clark Smith |
| Correspondent | Clark Smith KAY SEE DENTAL MFG. CO. 124 EAST MISSOURI AVE. Kansas City, MO 64106 -1294 |
| Product Code | EMA |
| CFR Regulation Number | 872.3275 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-19 |
| Decision Date | 1999-02-25 |
| Summary: | summary |