510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111423Substantially Equivalent

Cs 1600 Intraoral Camera

Eastman Kodak Company, Atlanta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111423 is the FDA 510(k) clearance record for CS 1600 INTRAORAL CAMERA, a class II device, cleared for Carestream Health, Inc. on under FDA product code NBL (Light-Induced Fluorescence Caries Detector). FDA records list 291 510(k) clearances for EASTMAN KODAK COMPANY, from to . As of , FDA records show no recalls naming K111423.

Clearance record

Decision date
Received
(284 days to decision)
Product code
NBL Light-Induced Fluorescence Caries Detector
Regulation
21 CFR 872.1745
Device class
Class II
Review panel
Dental
Applicant
Carestream Health, Inc. 1765 The Exchange, Atlanta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NBL

Trailing 12 months
1 clearance under product code NBL in the twelve months to October 2026, April 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code NBL, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260