510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862385Substantially Equivalent

Schein Bleaching Unit

Henry Schein, Inc., Port Washington NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862385 is the FDA 510(k) clearance record for SCHEIN BLEACHING UNIT, a class I device, cleared for Henry Schein, Inc. on under FDA product code EEG (Heat Source For Bleaching Teeth). FDA records list 8 510(k) clearances for Henry Schein, Inc., from to . As of , FDA records show no recalls naming K862385.

Clearance record

Decision date
Received
(128 days to decision)
Product code
EEG Heat Source For Bleaching Teeth
Regulation
21 CFR 872.6475
Device class
Class I
Review panel
Dental
Applicant
Henry Schein, Inc. 5 Harbor Park Dr., Port Washington NY
Third party review
No

Clearances, product code EEG

Trailing 12 months

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

FDA records show no clearances under product code EEG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EEG, 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