The following data is part of a premarket notification filed by Dentatus Usa, Ltd. with the FDA for Tuf Link Silicone Reliner.
| Device ID | K042931 |
| 510k Number | K042931 |
| Device Name: | TUF LINK SILICONE RELINER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
| Contact | Thomas Murphy |
| Correspondent | Thomas Murphy DENTATUS USA, LTD. 192 LEXINGTON AVE. New York, NY 10016 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-10-22 |
| Decision Date | 2004-12-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07350081494827 | K042931 | 000 |
| 07350081494810 | K042931 | 000 |