The following data is part of a premarket notification filed by Dentsply International, Inc. with the FDA for Ion Dental Resin System.
| Device ID | K072713 |
| 510k Number | K072713 |
| Device Name: | ION DENTAL RESIN SYSTEM |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 60 York, PA 17404 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNATIONAL, INC. 221 W. PHILADELPHIA ST. SUITE 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 | 2007-09-25 |
| Decision Date | 2007-10-12 |
| Summary: | summary |