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Schein Bleaching Unit

FDA 510(k)EUDAMED

Class I (US FDA 510(k))

510(k) K862385

by Henry Schein, Inc.

Identifiers

510(k) Number
K862385 FDA 510(k)
FDA Product Code
EEG FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 872.6475 FDA 510(k)
Regulation Number
872.6475 FDA 510(k)
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

A heat source for bleaching teeth, the Schein Bleaching Unit is designed to provide controlled thermal energy during dental bleaching procedures. It falls under the classification of a dental device, specifically intended for use in cosmetic dentistry to accelerate the bleaching process by applying heat to whitening agents applied to teeth.

This device is used in dental offices and is supplied as a reusable medical instrument. Authorized under FDA 510(k) clearance (K862385) and MDR, it operates as a Class I device under regulation number 872.6475. The unit is intended for single-patient use per session, with no specific sterility requirements stated beyond standard dental instrument reprocessing protocols. Multiple model and reference codes are associated with its regulatory submissions, though no MRI safety or size specifications are provided.

Frequently asked questions

What is the Schein Bleaching Unit primarily used for in a dental practice?

The Schein Bleaching Unit is designed to accelerate the dental bleaching process by applying controlled thermal energy to whitening agents applied to teeth. It is specifically intended for use in cosmetic dentistry to enhance the effectiveness of tooth whitening treatments during in-office procedures.

Is the Schein Bleaching Unit intended for single-use or reusable applications?

The Schein Bleaching Unit is supplied as a reusable medical instrument. While it is intended for single-patient use per session, it is not disposable and must be reprocessed according to standard dental instrument protocols between uses.

Are there any specific sterility requirements for the Schein Bleaching Unit?

The device does not specify unique sterility requirements beyond standard dental instrument reprocessing protocols. Since it is reusable, proper cleaning and sterilization between patients are essential to maintain safety and hygiene.

How is the regulatory status of the Schein Bleaching Unit defined?

The Schein Bleaching Unit is classified as a Class I medical device under FDA regulation number 872.6475. It holds an FDA 510(k) clearance (K862385) and is also authorized under the Medical Device Regulation (MDR). The device was determined to be substantially equivalent to a predicate through a traditional clearance process.

Does the Schein Bleaching Unit come in different sizes or models?

The provided data lists multiple reference codes associated with the Schein Bleaching Unit, which may correspond to different models or configurations. However, specific size or model variations (e.g., power settings, attachments, or physical dimensions) are not detailed in the data. For precise model specifications, consulting the manufacturer’s documentation or support would be necessary.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Schein Bleaching Unit 510 (k) FDA Premarket Notification K862385 HENRY ..., SCHEIN BLEACHING UNIT (K862385) — FDA 510(k) | Innolitics, FDA Browser - Cleared 510 (K) - SCHEIN BLEACHING UNIT (K862385), Superoxol 01155 In Office Bleaching Agent - Henry Schein

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Henry Schein, Inc.

Sources (2)

  • FDA 510(k) K862385 24 fields · synced Sep 19, 2026
  • EUDAMED 1 fields · synced May 25, 2026