Light-induced Fluorescence Caries Detector
Dental · 21 CFR 872.1745
Recent MDR events
6 adverse event reports on file
- DIAGNODENT CLASSICFeb 7, 2020MalfunctionKavo Dental Gmbh3003637274-2015-00005
- DIAGNODENT CLASSIC 2095Sep 22, 2017MalfunctionKavo Dental Gmbh3003637274-2017-00060
- KAVO DIAGNODENT 2095Dec 9, 2016MalfunctionKavo Dental Gmbh3003637274-2016-00074
- DIAGNODENT CLASSICJul 3, 2015MalfunctionKavo Dental Gmbh3003637274-2015-00013
- CLEAR-TRAC COMPLETE 5.5MM X 72MMAug 10, 2006MalfunctionSmith & Nephew, Inc., Endoscopy Division1219602-2006-00115
- CLEAR-TRAC COMPLETE 5.5MM X 72MMAug 2, 2006MalfunctionSmith & Nephew, Inc. Endoscopy Division1219602-2006-00106
Event type breakdown
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
27 firms currently registered for this product code
Sopro
LA CIOTAT CEDEX Bouches-du-Rhone, FR
3shape Poland Sp. Zo.o
Szczecin Zachodniopomorskie, PL
Durr Optronik Gmbh & Co. Kg
Gechingen Baden-Wurttemberg, DE
Dentsply Sirona Inc
York, PA, US
Marturion Electronics Ltd
Lisburn Northern Ireland, GB
Good Doctors Co., Ltd.
Incheon Seoul, KR
Kavo Dental Gmbh
WARTHAUSEN Baden-Wurttemberg, DE
3shape Inc.
Morrisville, NC, US
Zetta25 Ag
Zurich, CH
Sirona Dental Systems Gmbh
BENSHEIM Hesse, DE
Carl Zeiss Meditec (suzhou) Co., Ltd.
Suzhou Jiangsu, CN
Jenoptik Optical Systems Gmbh
Berlin, DE
3shape Inc
New Providence, NJ, US
3shape Trios A/s
copenhagen Hovedstaden, DK
Durr Dental Se
Bietigheim-Bissingen Baden-Wurttemberg, DE
Aiobio Co., Ltd.
Seongnam-si Gyeonggi, KR
Smartooth Co., Ltd.
Anyang-si Gyeonggi, KR
A-dec, Inc.
Newberg, OR, US
Dci International, Llc
NEWBERG, OR, US
510(k) clearances
24 clearances for this product code
- Zumax Medical Co., Ltd.Apr 28, 2026
K252464 · Surgical Microscope (OMS2360, OMS2380)
- 3Shape TRIOS A/SApr 4, 2025
K242103 · TRIOS Ready Tip
- AIOBIO Co., Ltd.Sep 4, 2024
K221275 · Qraycam PRO
- Smartooth Co., Ltd.May 1, 2024
K231722 · SmarTooth
- SoproDec 14, 2023
K223470 · C50
- 3Shape TRIOS A/SSep 16, 2022
K221249 · L1P-1F (TRIOS 5)
- Good Doctors Co., Ltd.Jul 2, 2020
K183471 · IC-WHCD100 (Inspire)
- Carl Zeiss Suzhou Co., Ltd.May 3, 2018
K171007 · Fluorescence Mode