The following data is part of a premarket notification filed by Sun Medical Co., Ltd with the FDA for Coating Material.
| Device ID | K150511 |
| 510k Number | K150511 |
| Device Name: | Coating Material |
| Classification | Resin, Denture, Relining, Repairing, Rebasing |
| Applicant | SUN MEDICAL CO., LTD 571-2 FURUTAKA-CHO Moriyama City, JP 524-0044 |
| Contact | Mr. Yukihito Yukimune |
| Correspondent | Carrie Hetrick EMERGO GROUP 816 CONGRESS AVENUE, SUITE 1400 Austin, TX 78701 |
| Product Code | EBI |
| CFR Regulation Number | 872.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-27 |
| Decision Date | 2015-05-27 |
| Summary: | summary |