510(k) K170822
K170822 is an FDA 510(k) premarket notification submitted by Ortek Therapeutics, Inc. for the device "Electronic Caries Detector". The FDA issued a decision of Substantially Equivalent on September 11, 2017. The device falls under product code NBL (Light-Induced Fluorescence Caries Detector), a Class II device regulated under 21 CFR 872.1745. Ortek Therapeutics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 2017
- Date Received
- March 20, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light-Induced Fluorescence Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type