510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K954061Substantially Equivalent

Poly-Lite Model 1000

Pro-Den Systems, Inc., Vancouver WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K954061 is the FDA 510(k) clearance record for POLY-LITE MODEL 1000, a class II device, cleared for Pro-Den Systems, Inc. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 2 510(k) clearances for Pro-Den Systems, Inc., from to . As of , FDA records show no recalls naming K954061.

Clearance record

Decision date
Received
(23 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Pro-Den Systems, Inc. 13915 NW 3rd Ct., Vancouver WA
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