The following data is part of a premarket notification filed by Orthoselect, Llc with the FDA for Dibs (digital Indirect Bonding System).
| Device ID | K192701 |
| 510k Number | K192701 |
| Device Name: | DIBS (Digital Indirect Bonding System) |
| Classification | Orthodontic Software |
| Applicant | OrthoSelect, LLC 831 E 340 S Suite 170 American Fork, UT 84003 |
| Contact | Steven N. Gardner |
| Correspondent | Carmine Jabri E.M.M.A International Consulting Group Inc. 27600 Farmington Road, Suite 100 Farmington Hills, MI 48334 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-27 |
| Decision Date | 2020-04-21 |