TIA Tip, Cariosity, Transillumination Accessory Tip
FDA 510(k) K213482 · D4D Technologies, LLC
510(k) numberK213482
Submission
- Device name
- TIA Tip, Cariosity, Transillumination Accessory Tip
- Applicant
- D4D Technologies, LLC
Richardson, TX, US - Received
- October 29, 2021
- Decision date
- April 29, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was TIA Tip, Cariosity, Transillumination Accessory Tip cleared by the FDA?
TIA Tip, Cariosity, Transillumination Accessory Tip (K213482) received a 510(k) decision of Substantially Equivalent on April 29, 2022, 182 days after the submission was received.
What is the product code of K213482?
The FDA product code is NTK – Light Transmission Caries Detector, a Class II (moderate risk) device regulated under 21 CFR 872.1745.