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
K063003Substantially Equivalent

Aurora

Parkell, Inc., Edgewood NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K063003 is the FDA 510(k) clearance record for AURORA, a class II device, cleared for Parkell, Inc. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 61 510(k) clearances for Parkell, Inc., from to . As of , FDA records show no recalls naming K063003.

Clearance record

Decision date
Received
(57 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Parkell, Inc. 300 Executive Dr., Edgewood NY
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