The following data is part of a premarket notification filed by Kay See Dental Mfg. Co. with the FDA for Hydro-cast Silicone Soft-liner, Model 68400.
| Device ID | K992609 |
| 510k Number | K992609 |
| Device Name: | HYDRO-CAST SILICONE SOFT-LINER, MODEL 68400 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| 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 | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-04 |
| Decision Date | 1999-09-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841549118524 | K992609 | 000 |
| 00841549118487 | K992609 | 000 |
| 00841549118319 | K992609 | 000 |
| 00841549115974 | K992609 | 000 |
| 00841549115967 | K992609 | 000 |