Caries Detector, Laser Light, Transmission

Product Code: NTK

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 NTK

1356Caries Detector, Laser Light, TransmissionLaser Fluorescence Caries Detection Device.

Total Product Life Cycle (TPLC) Devices

1356Caries Detector, Laser Light, TransmissionLaser Fluorescence Caries Detection Device.

Pre-market Notifications for NTK

K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC
K193659ITero Element 5DAlign Technology, Inc.
K182712DEXIS CariVu 3-in-1 By KaVoKaltenbach & Voigt GmbH
K172007CamX Triton HD Proxi HeadDuerr Dental AG
K123402DIAGNOCAMKALTENBACH & VOIGT GMBH
K062961MICROLUX TRANSILLUMINATORADDENT, INC.
K060080DIAGNODENT 2190 WITH PERIODONTAL PROBEKAVO DENTAL CORPORATION
K043068DIFOTI USB 2.0 SYSTEMELECTRO-OPTICAL SCIENCES, INC.

Global Unique Device Identification Database

EKAV101317000Caries detector, laser light, transmission
EKAV101144440Caries detector, laser light, transmission
E247J29101Caries Detector, Laser Light, Transmission
E247J29001Caries Detector, Laser Light, Transmission
E247J27001Caries Detector, Laser Light, Transmission
E247J26001Caries Detector, Laser Light, Transmission
E247J25101Caries Detector, Laser Light, Transmission
E247J25001Caries Detector, Laser Light, Transmission
D86962000706Caries Detector, Laser Light, Transmission
D86911008001Caries Detector, Laser Light, Transmission
EKAV101055700Caries detector, laser light, transmission
EKAV100484000Caries detector, laser light, transmission
EKAV100434000Caries detector, laser light, transmission
EKAV100403700Caries detector, laser light, transmission
EKAV057405000Caries detector, laser light, transmission

Maude Adverse Events

DIAGNODENT CLASSIC 2095KAVO DENTAL GMBH2017-10-16
DIAGNODENT CLASSIC 2095KAVO DENTAL GMBH2016-02-19
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