510(k) K192701
K192701 is an FDA 510(k) premarket notification submitted by Orthoselect, LLC for the device "DIBS (Digital Indirect Bonding System)". The FDA issued a decision of Substantially Equivalent on Apr 21, 2020. The device falls under product code PNN (Orthodontic Software), a Class II device regulated under 21 CFR 872.5470.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 21, 2020
- Date Received
- Sep 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthodontic Software
- Device Class
- Class II
- Regulation Number
- 872.5470
- Review Panel
- DE
- Submission Type
- 510(k)
The device is software that is to be used for the diagnosis and treatment planning of orthodontic patients and conditions. It may include orthodontic output devices used for the treatment of orthodontics. The device is intended for prescription use only.