510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K063321Substantially Equivalent

D-Carie/detectar, Models N121, N123, N133, N134, N135 & N138

Neks Technologies, Inc., Laval, Quebec, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K063321 is the FDA 510(k) clearance record for D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138, a class II device, cleared for Neks Technologies, Inc. on under FDA product code NBL (Light-Induced Fluorescence Caries Detector). FDA records list 3 510(k) clearances for Neks Technologies, Inc., from to . As of , FDA records show no recalls naming K063321.

Clearance record

Decision date
Received
(148 days to decision)
Product code
NBL Light-Induced Fluorescence Caries Detector
Regulation
21 CFR 872.1745
Device class
Class II
Review panel
Dental
Applicant
Neks Technologies, Inc. 2816, Joseph A. Bombardier, Laval, Quebec, CA
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