The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for Denture Relining, Repair/rebasing Resin.
| Device ID | K831647 |
| 510k Number | K831647 |
| Device Name: | DENTURE RELINING, REPAIR/REBASING 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 | 1983-05-23 |
| Decision Date | 1983-06-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D00195768010 | K831647 | 000 |
| D001899350 | K831647 | 000 |
| D001897810 | K831647 | 000 |
| D001897800 | K831647 | 000 |
| D001897790 | K831647 | 000 |
| D001892440 | K831647 | 000 |
| D001889780 | K831647 | 000 |
| D001889770 | K831647 | 000 |
| D001889750 | K831647 | 000 |
| D0019055300 | K831647 | 000 |
| D00195742010 | K831647 | 000 |
| D001957650 | K831647 | 000 |
| D001957510 | K831647 | 000 |
| D001957500 | K831647 | 000 |
| D00195743030 | K831647 | 000 |
| D00195743020 | K831647 | 000 |
| D00195743010 | K831647 | 000 |
| D00195742030 | K831647 | 000 |
| D00195742020 | K831647 | 000 |
| D001889261 | K831647 | 000 |