The following data is part of a premarket notification filed by Biomta with the FDA for Retromta-orthomta Ii.
| Device ID | K132825 |
| 510k Number | K132825 |
| Device Name: | RETROMTA-ORTHOMTA II |
| Classification | Resin, Root Canal Filling |
| Applicant | BIOMTA 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung BIOMTA 2651 E CHAPMAN AVE STE 110 Fullerton, CA 92833 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-09 |
| Decision Date | 2014-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800027200054 | K132825 | 000 |
| 08800027200047 | K132825 | 000 |
| 08800027200030 | K132825 | 000 |
| 08800027200023 | K132825 | 000 |