D-Carie, Model N121-M1

FDA 510(k) K043156 · Neks Technologies, Inc.

Substantially Equivalent

510(k) numberK043156

Submission

Device name
D-Carie, Model N121-M1
Applicant
Neks Technologies, Inc.
Durham, NC, US
Received
November 15, 2004
Decision date
April 28, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NBL – Light-Induced Fluorescence Caries Detector
Device class
Class II (moderate risk)
Regulation
21 CFR 872.1745
Specialty
Dental

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More from Durr Dental AG

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K063321D-Carie/Detectar, Models N121, N123, N133, N134, N135 & N138NBL · Traditional 03/30/2007SE
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Questions and answers

When was D-Carie, Model N121-M1 cleared by the FDA?

D-Carie, Model N121-M1 (K043156) received a 510(k) decision of Substantially Equivalent on April 28, 2005, 164 days after the submission was received.

What is the product code of K043156?

The FDA product code is NBL – Light-Induced Fluorescence Caries Detector , a Class II (moderate risk) device regulated under 21 CFR 872.1745.