iTero Lumina™ Pro
FDA 510(k) clearance K261847 · decided 2026-07-02
Clearance details
- K-number
- K261847
- Device name
- iTero Lumina™ Pro
- Applicant
- Align Technology , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2026-06-03
- Decision date
- 2026-07-02
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- NTK
- Device class
- 2
- Regulation number
- 872.1745
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Petach Tikva, IL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Primescan 2 (K250771) | Dentsply Sirona, Inc. | 2025-08-29 |
| iTero Lumina™ Pro (K240573) | Align Technology , Ltd. | 2024-08-16 |
| TIA Tip, Cariosity, Transillumination Accessory Tip (K213482) | D4D Technologies, LLC | 2022-04-29 |
| iTero Element 5D (K193659) | Align Technology, Inc. | 2020-03-20 |
| DEXIS CariVu 3-in-1 by KaVo (K182712) | Kaltenbach & Voigt GmbH | 2019-11-23 |
| CamX Triton HD Proxi Head (K172007) | Duerr Dental AG | 2017-11-22 |
| DIAGNOCAM (K123402) | Kaltenbach & Voigt GmbH | 2013-09-24 |
| TI2200 TRANSILLUMINATION CABLE (K071429) | Kerr Corporation | 2007-09-10 |
| MICROLUX TRANSILLUMINATOR (K062961) | Addent, Inc. | 2007-02-08 |
| DIAGNODENT 2190 WITH PERIODONTAL PROBE (K060080) | Kavo Dental Corporation | 2006-02-08 |
| DIFOTI USB 2.0 SYSTEM (K043068) | Electro-Optical Sciences, Inc. | 2004-12-29 |
Recalls involving this device
No recalls on record reference this clearance.