The following data is part of a premarket notification filed by Avalon Biomed Inc. with the FDA for Mta2 Root And Pulp Materials.
| Device ID | K122892 |
| 510k Number | K122892 |
| Device Name: | MTA2 ROOT AND PULP MATERIALS |
| Classification | Resin, Root Canal Filling |
| Applicant | AVALON BIOMED INC. 7282 55TH AVE E #227 Bradenton, FL 34203 |
| Contact | Carolyn Primus |
| Correspondent | Carolyn Primus AVALON BIOMED INC. 7282 55TH AVE E #227 Bradenton, FL 34203 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-20 |
| Decision Date | 2012-12-11 |
| Summary: | summary |