510(k) K181416
K181416 is an FDA 510(k) premarket notification submitted by Crane Dental Laboratory, Inc. for the device "Sapphire Dorsal Comfort Fit". The FDA issued a decision of Substantially Equivalent on Sep 17, 2019. The device falls under product code LRK (Device, Anti-Snoring), a Class II device regulated under 21 CFR 872.5570. Crane Dental Laboratory, Inc. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 17, 2019
- Date Received
- May 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Anti-Snoring
- Device Class
- Class II
- Regulation Number
- 872.5570
- Review Panel
- DE
- Submission Type
- 510(k)