The following data is part of a premarket notification filed by D4d Technologies, Llc with the FDA for Tia Tip, Cariosity, Transillumination Accessory Tip.
Device ID | K213482 |
510k Number | K213482 |
Device Name: | TIA Tip, Cariosity, Transillumination Accessory Tip |
Classification | Caries Detector, Laser Light, Transmission |
Applicant | D4D Technologies, LLC 2920 Telecom Parkway, Suite 100 Richardson, TX 75082 |
Contact | Eddie Anderson |
Correspondent | Eddie Anderson D4D Technologies, LLC 2920 Telecom Parkway, Suite 100 Richardson, TX 75082 |
Product Code | NTK |
CFR Regulation Number | 872.1745 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-10-29 |
Decision Date | 2022-04-29 |