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 |