Inspektor Pro
FDA 510(k) K040063 · Inspektor Dental Care BV
510(k) numberK040063
Submission
- Device name
- Inspektor Pro
- Applicant
- Inspektor Dental Care BV
Amsterdam, NL - Received
- January 13, 2004
- Decision date
- June 24, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code NBL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380)NBL · Traditional | Zumax Medical Co., Ltd. | 04/28/2026SE |
| K242103 | TRIOS Ready TipNBL · Traditional | 3Shape TRIOS A/S | 04/04/2025SE |
| K221275 | Qraycam PRONBL · Traditional | AIOBIO Co., Ltd. | 09/04/2024SE |
| K231722 | SmarToothNBL · Traditional | Smartooth Co., Ltd. | 05/01/2024SE |
| K223470 | C50NBL · Traditional | Sopro | 12/14/2023SE |
| K221249 | L1P-1F (Trios 5)NBL · Traditional | 3Shape TRIOS A/S | 09/16/2022SE |
| K183471 | IC-WHCD100 (Inspire)NBL · Traditional | Good Doctors Co., Ltd. | 07/02/2020SE |
| K171007 | Fluorescence ModeNBL · Traditional | Carl Zeiss Suzhou Co., Ltd. | 05/03/2018SE |
| K170822 | Electronic Caries DetectorNBL · Traditional | Ortek Therapeutics, Inc. | 09/11/2017SE |
| K150672 | VistaCam iX ProofNBL · Traditional | Durr Dental AG | 01/27/2016SE |
Questions and answers
When was Inspektor Pro cleared by the FDA?
Inspektor Pro (K040063) received a 510(k) decision of Substantially Equivalent on June 24, 2004, 163 days after the submission was received.
What is the product code of K040063?
The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.