510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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NTKClass II

Light Transmission Caries Detector

21 CFR 872.1745 / Dental
FDA source (opens on fda.gov)

NTK is the FDA product code for Light Transmission Caries Detector, a class II device type, regulated under 21 CFR 872.1745. As of , FDA records hold 12 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
NTK
Device name
Light Transmission Caries Detector
Regulation
21 CFR 872.1745
Device class
Class II
Review panel
Dental
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
12
Ingested recalls
0

Clearances, product code NTK

By decision year
12 clearances under product code NTK with a decision year between 2004 and 2026, 2007 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code NTK by decision year
YearClearances
20041
20061
20072
20131
20171
20191
20201
20221
20241
20251
20261

Applicants with the most clearances

Product code NTK
Applicants holding the most 510(k) clearances under product code NTK
ApplicantClearances
Align Technology, Inc.3
Kaltenbach & Voigt GmbH2
Addent, Inc.1
D4D Technologies1
Dentsply Sirona Inc1
Duerr Dental AG1
Electro-Optical Sciences, Inc.1
KaVo Dental GmbH1
Sybron Dental Specialties, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 20 companies shown, in name order