The following data is part of a premarket notification filed by Xpdent Corp. with the FDA for Wiedent Estetic.
| Device ID | K061337 |
| 510k Number | K061337 |
| Device Name: | WIEDENT ESTETIC |
| Classification | Denture, Plastic, Teeth |
| Applicant | XPDENT CORP. 12145 S.W. 131ST AVE. Miami, FL 33186 |
| Contact | Carmen Perez |
| Correspondent | Carmen Perez XPDENT CORP. 12145 S.W. 131ST AVE. Miami, FL 33186 |
| Product Code | ELM |
| CFR Regulation Number | 872.3590 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-12 |
| Decision Date | 2006-06-07 |