510(k) Report

510(k) · Cleared

Cleared

Schein Bleaching Unit

K862385510(k) TraditionalCleared Oct 30, 1986128-day reviewClass I21 CFR 872.6475

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Henry Schein, Inc. · EEG Heat Source For Bleaching Teeth

Cleared on Oct 30, 1986 after a 128-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Oct 30, 1986
Review
128 days
Class
Class I
Product code
EEG
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K862385Source: FDA 510(k) database · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in EEG? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

How does its category compare?

All EEG devices

EEG Heat Source For Bleaching Teeth: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EEG

2in 2012

2007: 12012: 2
2007high 2 (2012) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EEG

Too few EEG 510(k)s in any year since 2007 to give a median.

Recalls per year · EEG

No recall names EEG since 2007.

Adverse event reports per year · EEG

7in 2025

2007: 32008: 32010: 32011: 72012: 22013: 22014: 72015: 12016: 82017: 102018: 62019: 32020: 62021: 62022: 42024: 12025: 7
2007high 10 (2017) · low 0 (2009)2025

MAUDE reports naming product code EEG, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—03
20080—03
20090—00
20100—03
20110—07
20122—02
20130—02
20140—07
20150—01
20160—08
20170—010
20180—06
20190—03
20200—06
20210—06
20220—04
20230—00
20240—01
20250—07
20260—0—

More from Henry Schein, Inc.

8 FDA decisions under this applicant name. See the company

  • K041580ImagerayiHenry Schein, Inc. · 2004
  • K862384Schein AP-1 Air Polishing UnitHenry Schein, Inc. · 1986
  • K841199Fiberglass Mouth MirrorsHenry Schein, Inc. · 1984
  • K834055Vanadium Excavators Sizes 0-6Henry Schein, Inc. · 19848 recalls
  • K834056Schein Cotton Rolls, Non-SterileHenry Schein, Inc. · 1984

Recent decisions in EEG

The EEG category page

  • K122725Tanda Pearl, Ultrawyte, PearlSyneron Beauty · 2012
  • K110888Absolute White LightDr. Fresh, Inc. · 2012
  • K063704Britewhite Teeth Whitening System, Model BW1101Beks Incorporated · 2007
  • K052040QuicksmileCosmetic Dental Materials, Inc. · 2005
  • K041392Sonx 35 Ultrasonic Bleaching System; Soniwhite Ultra Sonic, Model Quick White USCAO Group, Inc. · 2004

https://510kreport.com/device/K862385 · printed Nov 4, 2026

Cite this page

510(k) Report. “K862385: Schein Bleaching Unit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K862385

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026