The following data is part of a premarket notification filed by Comfort Acrylics Co. with the FDA for Comfort Acrylics Pliable Denture Liners & Splints.
| Device ID | K900799 |
| 510k Number | K900799 |
| Device Name: | COMFORT ACRYLICS PLIABLE DENTURE LINERS & SPLINTS |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | COMFORT ACRYLICS CO. 2103 NE 272ND AVE. Camas, WA 98607 |
| Contact | Moore, Dds |
| Correspondent | Moore, Dds COMFORT ACRYLICS CO. 2103 NE 272ND AVE. Camas, WA 98607 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-02-20 |
| Decision Date | 1990-05-15 |