The following data is part of a premarket notification filed by Do Co., Ltd. with the FDA for Ortho Mta (mineral Trioxide Aggregate).
| Device ID | K102575 |
| 510k Number | K102575 |
| Device Name: | ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) |
| Classification | Resin, Root Canal Filling |
| Applicant | DO CO., LTD. 2341 W. CRESCENT AVE #3 Anaheim, CA 92801 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung DO CO., LTD. 2341 W. CRESCENT AVE #3 Anaheim, CA 92801 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-08 |
| Decision Date | 2010-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800027200078 | K102575 | 000 |
| 08800027200061 | K102575 | 000 |