The following data is part of a premarket notification filed by Avalon Biomed Inc. with the FDA for Mta2.2 Material.
| Device ID | K161239 |
| 510k Number | K161239 |
| Device Name: | MTA2.2 MATERIAL |
| Classification | Resin, Root Canal Filling |
| Applicant | AVALON BIOMED INC. 1912 44TH AVE E Bradenton, FL 34203 |
| Contact | Carolyn Primus |
| Correspondent | Carolyn Primus AVALON BIOMED INC. 1912 44TH AVE E 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 | 2016-05-02 |
| Decision Date | 2016-09-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850008515057 | K161239 | 000 |
| 00850008515040 | K161239 | 000 |
| 00850008515033 | K161239 | 000 |
| 00850008515026 | K161239 | 000 |
| 00850008515019 | K161239 | 000 |
| 00850008515002 | K161239 | 000 |