Laser, Fluorescence Caries Detection

Product Code: NBL

Dental Medical Laser Products

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: Laser Products. [1040.10] Specific Purpose Laser Products. [1040.11]

Code of Federal Regulations: 872.1745


Radiation TypeOptical
Radition SafetyProduct
Annual ReportsYes

Products Classified as NBL

1330Laser, Fluorescence Caries DetectionLaser Fluorescence Caries Detection Device.

Total Product Life Cycle (TPLC) Devices

1330Laser, Fluorescence Caries DetectionLaser Fluorescence Caries Detection Device.

Pre-market Notifications for NBL

K221249L1P-1F (TRIOS 5)3Shape TRIOS A/S
K183471IC-WHCD100 (Inspire)Good Doctors Co.,Ltd.
K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd.
K170822Electronic Caries DetectorOrtek Therapeutics, Inc.
K150672VistaCam IX ProofDurr Dental AG
K121685SOPROCARESOPRO
K112139THE CANARY SYSTEMQUANTUM DENTAL TECHNOLOGIES INC
K111423CS 1600 INTRAORAL CAMERACARESTREAM HEALTH,INC.
K111321REMOTE VIEW SOFTWARECARIESCAN LTD.
K093705FUORECAMTHERAPEUTIC TECHNOLOGIES, INC.
K092583SOPROLIFESOPRO
K090598CARIESCAN PROCARIESCAN LTD.
K090169SPECTRA FLUORESCENCE CARIES DETECTION DEVICEAIR TECHNIQUES, INC.
K063321D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138NEKS TECHNOLOGIES, INC.
K051909DIAGNODENTKAVO AMERICA

Global Unique Device Identification Database

06909262100043Laser, Fluorescence Caries Detection
60889974007909Laser,fluorescence caries detection
E247J27101Laser, Fluorescence Caries Detection
E247J23101Laser, Fluorescence Caries Detection
EKAV100416400Laser,fluorescence caries detection
M430S90000041Laser,Fluorescence Caries Detection
M430S90000021Laser,Fluorescence Caries Detection
03760278262773Laser,Fluorescence Caries Detection
03760278261356Laser,Fluorescence Caries Detection
03760278261332Laser,Fluorescence Caries Detection
03760278260304Laser,Fluorescence Caries Detection
03760278260212Laser,Fluorescence Caries Detection
03760278260205Laser,Fluorescence Caries Detection
03760278260175Laser,Fluorescence Caries Detection
03760278260168Laser,Fluorescence Caries Detection

Maude Adverse Events

DIAGNODENT CLASSICKAVO DENTAL GMBH2020-02-07
DIAGNODENT CLASSIC 2095KAVO DENTAL GMBH2017-09-22
KAVO DIAGNODENT 2095KAVO DENTAL GMBH2016-12-09
DIAGNODENT CLASSICKAVO DENTAL GMBH2015-07-03
CLEAR-TRAC COMPLETE 5.5MM X 72MMSMITH & NEPHEW, INC., ENDOSCOPY DIVISION2006-08-10
CLEAR-TRAC COMPLETE 5.5MM X 72MMSMITH & NEPHEW, INC. ENDOSCOPY DIVISION2006-08-02
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