510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K901908Substantially Equivalent

Heliolux Visible Curing Light

Ivoclar North America, Inc., Amherst NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901908 is the FDA 510(k) clearance record for HELIOLUX VISIBLE CURING LIGHT, a class II device, cleared for Ivoclar North America, Inc. on under FDA product code EBZ (Activator, Ultraviolet, For Polymerization). FDA records list 131 510(k) clearances for Ivoclar North America, Inc., from to . As of , FDA records show no recalls naming K901908.

Clearance record

Decision date
Received
(78 days to decision)
Product code
EBZ Activator, Ultraviolet, For Polymerization
Regulation
21 CFR 872.6070
Device class
Class II
Review panel
Dental
Applicant
Ivoclar North America, Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code EBZ

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