The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos Sa with the FDA for Fusion Single Link.
| Device ID | K132923 |
| 510k Number | K132923 |
| Device Name: | FUSION SINGLE LINK |
| Classification | Agent, Tooth Bonding, Resin |
| Applicant | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Contact | Tara Conrad |
| Correspondent | Tara Conrad ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS SA 18851 NE 29TH AVE 720 Aventura, FL 33180 |
| Product Code | KLE |
| CFR Regulation Number | 872.3200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-18 |
| Decision Date | 2014-01-03 |
| Summary: | summary |