The following data is part of a premarket notification filed by Takara Belmont Corp. with the FDA for Bel-cat.
| Device ID | K101181 |
| 510k Number | K101181 |
| Device Name: | BEL-CAT |
| Classification | X-ray, Tomography, Computed, Dental |
| Applicant | TAKARA BELMONT CORP. 8870 RAVELLO COURT Naples, FL 34114 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm TAKARA BELMONT CORP. 8870 RAVELLO COURT Naples, FL 34114 |
| Product Code | OAS |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-27 |
| Decision Date | 2011-07-19 |
| Summary: | summary |