The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Adseal Root Canal Sealer.
| Device ID | K042769 |
| 510k Number | K042769 |
| Device Name: | ADSEAL ROOT CANAL SEALER |
| Classification | Resin, Root Canal Filling |
| Applicant | META BIOMED CO., LTD. 41-19, 77TH STREET Elmhurst, NY 11373 |
| Contact | Jenny Shon |
| Correspondent | Neil 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 | 2004-10-05 |
| Decision Date | 2004-11-24 |
| Summary: | summary |