The following data is part of a premarket notification filed by Angelus Industria De Productos Odontologicos with the FDA for Perma Fiber,model 441; Perma Mesh, Model 440.
| Device ID | K082180 |
| 510k Number | K082180 |
| Device Name: | PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-08-01 |
| Decision Date | 2008-12-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07898078659403 | K082180 | 000 |
| 07898078659298 | K082180 | 000 |
| 07898078659281 | K082180 | 000 |
| 07898078659274 | K082180 | 000 |
| 07898078659267 | K082180 | 000 |
| 07898078659243 | K082180 | 000 |
| 07898078659236 | K082180 | 000 |