The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Metapex Calcium Hydroxide With Lodoform Temporary Root Canal Filling.
| Device ID | K032603 |
| 510k Number | K032603 |
| Device Name: | METAPEX CALCIUM HYDROXIDE WITH LODOFORM TEMPORARY ROOT CANAL FILLING |
| Classification | Resin, Root Canal Filling |
| Applicant | META BIOMED CO., LTD. 41-19, 77TH STREET Elmhurst, NY 11373 |
| Contact | Jenny Shon |
| Correspondent | Ned E Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | KIF |
| CFR Regulation Number | 872.3820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-08-25 |
| Decision Date | 2003-10-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387893257 | K032603 | 000 |
| 08806387892014 | K032603 | 000 |
| 08806387892007 | K032603 | 000 |