Light Transmission Caries Detector
Dental · 21 CFR 872.1745
Recent MDR events
5 adverse event reports on file
- ITERO ELEMENT 5D US SYSTEMSep 30, 2025MalfunctionAlign Technology, Ltd.3009646999-2025-00602
- ITERO ELEMENT 5D PLUS CART CONFIGURATIONJul 8, 2025MalfunctionAlign Technology, Ltd.3009646999-2025-00461
- ITERO ELEMENT 5D US SYSTEMOct 9, 2023InjuryAlign Technology, Ltd.3009646999-2023-02943
- ITERO ELEMENT 5D PLUS CART CONFIGURATIONAug 9, 2023MalfunctionAlign Technology, Ltd.3009646999-2023-02160
- DIAGNODENT CLASSIC 2095Oct 16, 2017MalfunctionKavo Dental Gmbh3003637274-2017-00062
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
35 firms currently registered for this product code
Planmeca Oy
Helsinki Uusimaa, FI
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Dentsply North America Llc
Lancaster, PA, US
Henry Schein Services Gmbh
Gallin Mecklenburg-Western Pomerania, DE
Dentsply Sirona Inc
York, PA, US
Ivoclar Vivadent Ag
SCHAAN, LI
Durr Dental Se
Bietigheim-Bissingen Baden-Wurttemberg, DE
Ivoclar Vivadent, Inc.
Mississauga Ontario, CA
Fabrinet Co., Ltd.
Sriracha Chon Buri, TH
Zetta25 Ag
Zurich, CH
Kavo Dental Gmbh
WARTHAUSEN Baden-Wurttemberg, DE
Sirona Dental Systems Gmbh
BENSHEIM Hesse, DE
Align Technology, Inc.
San Jose, CA, US
Addent, Inc.
DANBURY, CT, US
Jenoptik Optical Systems Gmbh
Berlin, DE
Zapalign Llc
Fort Lauderdale, FL, US
Align Technology, Ltd.
Petach Tikva Central, IL
Aligntech De Mexico S, De R. L. De C. V.
Cd. Juarez Chihuahua, MX
Align Technology De Costa Rica S.r.l
Belen Heredia, CR
510(k) clearances
12 clearances for this product code
- Align Technology , Ltd.Jul 2, 2026
K261847 · iTero Lumina Pro
- Dentsply Sirona, Inc.Aug 29, 2025
K250771 · Primescan 2
- Align Technology , Ltd.Aug 16, 2024
K240573 · iTero Lumina Pro
- D4D Technologies, LLCApr 29, 2022
K213482 · TIA Tip, Cariosity, Transillumination Accessory Tip
- Align Technology, Inc.Mar 20, 2020
K193659 · iTero Element 5D
- Kaltenbach & Voigt GmbHNov 23, 2019
K182712 · DEXIS CariVu 3-in-1 by KaVo
- Duerr Dental AGNov 22, 2017
K172007 · CamX Triton HD Proxi Head
- Kaltenbach & Voigt GmbHSep 24, 2013
K123402 · DIAGNOCAM