The following data is part of a premarket notification filed by Kay See Dental Mfg. Co. with the FDA for Hydro-cast Dental Etching Gel, Model 60025.
| Device ID | K990306 |
| 510k Number | K990306 |
| Device Name: | HYDRO-CAST DENTAL ETCHING GEL, MODEL 60025 |
| Classification | Sealant, Pit And Fissure, And Conditioner |
| 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 | EBC |
| CFR Regulation Number | 872.3765 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-02-01 |
| Decision Date | 1999-03-03 |
| Summary: | summary |