510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K130163Substantially Equivalent

D-Lux

Diadent Group International, Chungcheong Buk-Do, KR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K130163 is the FDA 510(k) clearance record for D-LUX, a class II device, cleared for DiaDent Group International on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 22 510(k) clearances for DiaDent Group International, from to . As of , FDA records show no recalls naming K130163.

Clearance record

Decision date
Received
(205 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
DiaDent Group International 626, Yeonje-Ri, Gangoe-Myeon, Chungcheong Buk-Do, KR
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code EBZ

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