FDA Product Code
FDA Product Code NTK — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.1745
510(k) Clearances — 12 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K261847 | iTero Lumina Pro | Align Technology , Ltd. | 2026-07-02 | Special | PDF ↗ |
| K250771 | Primescan 2 | Dentsply Sirona, Inc. | 2025-08-29 | Traditional | PDF ↗ |
| K240573 | iTero Lumina Pro | Align Technology , Ltd. | 2024-08-16 | Traditional | PDF ↗ |
| K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | 2022-04-29 | Traditional | PDF ↗ |
| K193659 | iTero Element 5D | Align Technology, Inc. | 2020-03-20 | Traditional | PDF ↗ |
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | 2019-11-23 | Traditional | PDF ↗ |
| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | 2017-11-22 | Traditional | PDF ↗ |
| K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | 2013-09-24 | Traditional | PDF ↗ |
| K071429 | TI2200 TRANSILLUMINATION CABLE | Kerr Corporation | 2007-09-10 | Traditional | PDF ↗ |
| K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | 2007-02-08 | Traditional | PDF ↗ |
| K060080 | DIAGNODENT 2190 WITH PERIODONTAL PROBE | Kavo Dental Corporation | 2006-02-08 | Special | PDF ↗ |
| K043068 | DIFOTI USB 2.0 SYSTEM | Electro-Optical Sciences, Inc. | 2004-12-29 | Traditional | PDF ↗ |
Product code NTK · Class II · Dental. Data: openFDA.