The following data is part of a premarket notification filed by Dentsply Interntional with the FDA for Composite Aligner Button.
| Device ID | K080246 |
| 510k Number | K080246 |
| Device Name: | COMPOSITE ALIGNER BUTTON |
| Classification | Aligner, Sequential |
| Applicant | DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17405 |
| Contact | Helen Lewis |
| Correspondent | Helen Lewis DENTSPLY INTERNTIONAL 221 W. PHILADELPHIA ST. STE.60 SUSQUEHANNA COMMERCE CRT. WEST York, PA 17405 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-31 |
| Decision Date | 2008-04-11 |
| Summary: | summary |