510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823409Substantially Equivalent

Heliosit-Orthodontic

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

K823409 is the FDA 510(k) clearance record for HELIOSIT-ORTHODONTIC, a class II device, cleared for Vivadent (Usa), Inc. on under FDA product code DYH (Adhesive, Bracket And Tooth Conditioner, Resin). FDA records list 17 510(k) clearances for Vivadent (Usa), Inc., from to . As of , FDA records show no recalls naming K823409.

Clearance record

Decision date
Received
(67 days to decision)
Product code
DYH Adhesive, Bracket And Tooth Conditioner, Resin
Regulation
21 CFR 872.3750
Device class
Class II
Review panel
Dental
Applicant
Vivadent (Usa), Inc. 175 Pineview Dr., Amherst NY
Third party review
No

Clearances, product code DYH

Trailing 12 months
2 clearances under product code DYH 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 DYH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20261
August 20260
September 20260
October 20260