The following data is part of a premarket notification filed by Kay See Dental Mfg. Co. with the FDA for Hydro-cast Bis-acryl Temporary Crown And Bridge Material, Model 98250.
| Device ID | K001309 |
| 510k Number | K001309 |
| Device Name: | HYDRO-CAST BIS-ACRYL TEMPORARY CROWN AND BRIDGE MATERIAL, MODEL 98250 |
| Classification | Crown And Bridge, Temporary, Resin |
| 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 | EBG |
| CFR Regulation Number | 872.3770 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-04-25 |
| Decision Date | 2000-06-13 |