510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802684Substantially Equivalent

Heliomat

Vivadent (USA), Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802684 is the FDA 510(k) clearance record for HELIOMAT, a class I device, cleared for Vivadent (Usa), Inc. on under FDA product code EAY (Light, Fiber Optic, Dental). FDA records list 17 510(k) clearances for Vivadent (Usa), Inc., from to . As of , FDA records show no recalls naming K802684.

Clearance record

Decision date
Received
(27 days to decision)
Product code
EAY Light, Fiber Optic, Dental
Regulation
21 CFR 872.4620
Device class
Class I
Review panel
Dental
Applicant
Vivadent (Usa), Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EAY

Trailing 12 months

FDA records hold no clearances under product code EAY in the trailing twelve months.

FDA records show no clearances under product code EAY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EAY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260