The following data is part of a premarket notification filed by Dentsply International with the FDA for Eclipse Wax Remover.
| Device ID | K061580 |
| 510k Number | K061580 |
| Device Name: | ECLIPSE WAX REMOVER |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTERNATIONAL SUSQUEHANNA COMMERCE CTR. WEST 221 W. PHILADELPHIA ST., #60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL SUSQUEHANNA COMMERCE CTR. WEST 221 W. PHILADELPHIA ST., #60 York, PA 17404 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-07 |
| Decision Date | 2006-07-28 |
| Summary: | summary |