510(k) K213482
K213482 is an FDA 510(k) premarket notification submitted by D4D Technologies, LLC for the device "TIA Tip, Cariosity, Transillumination Accessory Tip". The FDA issued a decision of Substantially Equivalent on April 29, 2022. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. D4D Technologies, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2022
- Date Received
- October 29, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Light Transmission Caries Detector
- Device Class
- Class II
- Regulation Number
- 872.1745
- Review Panel
- DE
- Submission Type