510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K042196Substantially Equivalent

Savedent Blue

Denfotex Light Systems, Ltd., Inverkeithing Fife, Scotland, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042196 is the FDA 510(k) clearance record for SAVEDENT BLUE, a class II device, cleared for Denfotex Light Systems, Ltd. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list one 510(k) clearance for Denfotex Light Systems, Ltd. As of , FDA records show no recalls naming K042196.

Clearance record

Decision date
Received
(80 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Denfotex Light Systems, Ltd. Unit 15, Belleknowes Ind.Est, Inverkeithing Fife, Scotland, GB
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