510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K002991Substantially Equivalent

Zap Dual Curing Light

Soft-Core Texas, Inc., North Richland Hills TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002991 is the FDA 510(k) clearance record for ZAP DUAL CURING LIGHT, a class II device, cleared for Soft-Core Texas, Inc. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 2 510(k) clearances for Soft-Core Texas, Inc., from to . As of , FDA records show no recalls naming K002991.

Clearance record

Decision date
Received
(64 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Soft-Core Texas, Inc. 5424 Rufe Snow Dr., #102, North Richland Hills TX
510(k) summary
Statement
Third party review
No

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