510(k) K161884
K161884 is an FDA 510(k) premarket notification submitted by 3Shape A/S for the device "Ortho System". The FDA issued a decision of Substantially Equivalent on April 19, 2017. The device falls under product code MQC (Mouthguard, Prescription), a Class U device. 3Shape A/S has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 19, 2017
- Date Received
- July 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mouthguard, Prescription
- Device Class
- Class U
- Regulation Number
- Review Panel
- DE
- Submission Type