FDA Product Code
FDA Product Code NBL — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1745
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | 2026-04-28 | Traditional | PDF ↗ |
| K242103 | TRIOS Ready Tip | 3Shape TRIOS A/S | 2025-04-04 | Traditional | PDF ↗ |
| K221275 | Qraycam PRO | AIOBIO Co., Ltd. | 2024-09-04 | Traditional | PDF ↗ |
| K231722 | SmarTooth | Smartooth Co., Ltd. | 2024-05-01 | Traditional | PDF ↗ |
| K223470 | C50 | Sopro | 2023-12-14 | Traditional | PDF ↗ |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | 2022-09-16 | Traditional | PDF ↗ |
| K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | 2020-07-02 | Traditional | PDF ↗ |
| K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | 2018-05-03 | Traditional | PDF ↗ |
| K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | 2017-09-11 | Traditional | PDF ↗ |
| K150672 | VistaCam iX Proof | Durr Dental AG | 2016-01-27 | Traditional | PDF ↗ |
| K121685 | SOPROCARE | Sopro | 2013-03-12 | Traditional | PDF ↗ |
| K112139 | THE CANARY SYSTEM | Quantum Dental Technologies, Inc. | 2012-10-26 | Traditional | PDF ↗ |
| K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | 2012-03-02 | Traditional | PDF ↗ |
| K111321 | REMOTE VIEW SOFTWARE | Cariescan , Ltd. | 2011-05-17 | Special | PDF ↗ |
| K093705 | FUORECAM | Therapeutic Technologies, Inc. | 2010-04-23 | Traditional | PDF ↗ |
| K092583 | SOPROLIFE | Sopro | 2010-01-13 | Traditional | PDF ↗ |
| K090598 | CARIESCAN PRO | Cariescan , Ltd. | 2009-12-15 | Traditional | PDF ↗ |
| K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Air Techniques, Inc. | 2009-08-18 | Traditional | PDF ↗ |
| K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | 2007-03-30 | Traditional | PDF ↗ |
| K051909 | DIAGNODENT | Kavo America | 2005-10-21 | Traditional | PDF ↗ |
| K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America Corporation | 2005-08-02 | Traditional | PDF ↗ |
| K043156 | D-CARIE, MODEL N121-M1 | Neks Technologies, Inc. | 2005-04-28 | Traditional | PDF ↗ |
| K040063 | INSPEKTOR PRO | Inspektor Dental Care BV | 2004-06-24 | Traditional | PDF ↗ |
| DEN990002 | KAVO DIAGNODENT | Kavo America | 2000-02-22 | Post-NSE | — |
Product code NBL · Class II · Dental. Data: openFDA.