The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Denture Base Resin.
| Device ID | K834409 |
| 510k Number | K834409 |
| Device Name: | DENTURE BASE RESIN |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTL. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-14 |
| Decision Date | 1984-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D001957580 | K834409 | 000 |
| D001957570 | K834409 | 000 |
| D00195745020 | K834409 | 000 |
| D00195745010 | K834409 | 000 |
| D00195744020 | K834409 | 000 |
| D00195744010 | K834409 | 000 |