Product code NTK
- Device name
- Caries Detector, Laser Light, Transmission
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.1745
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250771 | Primescan 2 | Dentsply Sirona, Inc. | 2025-08-29 |
| K240573 | iTero Lumina™ Pro | Align Technology , Ltd. | 2024-08-16 |
| K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | 2022-04-29 |
| K193659 | iTero Element 5D | Align Technology, Inc. | 2020-03-20 |
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | 2019-11-23 |
| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017-11-22 |
| K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | 2013-09-24 |
| K071429 | TI2200 TRANSILLUMINATION CABLE | Kerr Corporation | 2007-09-10 |
| K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | 2007-02-08 |
| K060080 | DIAGNODENT 2190 WITH PERIODONTAL PROBE | Kavo Dental Corporation | 2006-02-08 |
| K043068 | DIFOTI USB 2.0 SYSTEM | Electro-Optical Sciences, Inc. | 2004-12-29 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| E27668082030 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-11-21 |
| E27668082450 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-10-23 |
| E27668053651 | Primescan 2 Multiuse Sleeve | SIRONA Dental Systems GmbH | 2025-09-16 |
| E27668558402 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-08-20 |
| E27668020400 | Primescan 2 | SIRONA Dental Systems GmbH | 2025-05-16 |
| 00816063023067 | iTero Lumina Pro | Align Technology, Inc. | 2025-03-06 |
| 04262352350035 | DI Scan | Zetta25 AG | 2025-02-21 |
| 10194665007928 | A-dec | A-DEC, INC. | 2025-02-11 |
| EKAV101537000 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-12-03 |
| 00816063022657 | iTero Lumina Pro | Align Technology, Inc. | 2024-11-19 |
| 00816063022589 | iTero Lumina Pro Wand Barrier Sleeves | Align Technology, Inc. | 2024-11-19 |
| 00816063022466 | iTero Lumina Pro Upgrade | Align Technology, Inc. | 2024-11-19 |
| 00816063022442 | iTero Lumina Pro Mobile Upgrade | Align Technology, Inc. | 2024-11-19 |
| 00816063022428 | iTero Lumina Pro Upgrade | Align Technology, Inc. | 2024-11-19 |
| 00816063022329 | iTero Lumina Pro DOA | Align Technology, Inc. | 2024-11-19 |
| 00816063022268 | iTero Lumina Pro intraoral scanning unit | Align Technology, Inc. | 2024-11-19 |
| 00816063022237 | iTero Lumina Pro Mobile | Align Technology, Inc. | 2024-11-19 |
| 00816063022213 | iTero Lumina Pro | Align Technology, Inc. | 2024-11-19 |
| 00816063022664 | iTero Lumina Pro | Align Technology, Inc. | 2024-11-19 |
| EKAV101315000 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-02-01 |
| EKAV101112130 | DIAGNOcam Vision Full HD | KaVo Dental GmbH | 2024-02-01 |
| 00858809006224 | Planmeca Emerald S | D4D TECHNOLOGIES, LLC | 2022-07-06 |
| EKAV100270000 | DIAGNOdent pen 2190 | KaVo Dental GmbH | 2022-04-15 |
| E247J27131 | CamX Proxi Interchangeable Head | DÜRR DENTAL SE | 2022-03-04 |
| 00816063020691 | iTero Element 5D Plus cart configuration | Align Technology, Inc. | 2021-06-04 |
| 00816063020820 | iTero Wheel stand | Align Technology, Inc. | 2021-06-04 |
| 00816063020707 | iTero Element 5D Plus US cart configuration | Align Technology, Inc. | 2021-06-04 |
| 00816063020844 | iTero Mobile Computing Unit | Align Technology, Inc. | 2021-06-04 |
| 00816063020837 | iTero Computing Unit | Align Technology, Inc. | 2021-06-04 |
| 00858809006170 | Planmeca Emerald S | D4D TECHNOLOGIES, LLC | 2019-03-28 |