| K-number | K090355 |
| Device name | OPAL SEAL |
| Applicant | Ultradent Products, Inc. |
| Product code | DYH |
| Device class | Class II |
| Decision date | Apr 29, 2009 |
| Decision | Substantially Equivalent |
| Regulation | 872.3750 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov