The following data is part of a premarket notification filed by Takara-belmont Co., Ltd. with the FDA for Bel-cypher, Model Y977.
| Device ID | K090020 |
| 510k Number | K090020 |
| Device Name: | BEL-CYPHER, MODEL Y977 |
| Classification | System, X-ray, Extraoral Source, Digital |
| Applicant | TAKARA-BELMONT CO., LTD. 101 BELMONT DRIVE Somerset, NJ 08873 -1204 |
| Contact | Kunihiko Sobue |
| Correspondent | Kunihiko Sobue TAKARA-BELMONT CO., LTD. 101 BELMONT DRIVE Somerset, NJ 08873 -1204 |
| Product Code | MUH |
| CFR Regulation Number | 872.1800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-05 |
| Decision Date | 2009-03-13 |
| Summary: | summary |