Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

1 warning recorded — scroll inside the panel to see all entries.

• CW999

  Avoid direct contact of the active surface of the tooth whitening product with the gums and/or salivary flow. Some patients may experience temporary discomfort of the gums, lips, throat, tongue, or teeth. Should any of these symptoms persist or worsen after discontinuing use, or in cases of severe discomfort, call your dental professional. If the product is ingested, drink large amounts of water and contact a physician. If the product is aspirated, seek immediate medical attention. Patients with serious health concerns should consult their primary care provider prior to treatment. Avoid contact with eyes. Rinse immediately if product comes into contact with them.

Primary placement in Germany; available across 28 countries total.

Trade name

Opalescence Quick 45% PF

UDI-DI code

Primary DI

The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED.

00883205103055

Basic UDI-DI

Basic UDI-DI

The Basic UDI-DI is the main identifier that groups together all device variants of the same model — the regulatory "family" key.

0883205-TF226B7

Reference / catalog number

5346

Issuing entity

UDI issuing entities

Issuing entities are the organisations the European Commission has designated to assign Unique Device Identifiers under the EU's UDI system.

GS1

Risk category

MDR risk classes

MDR risk classes rank medical devices from lowest risk (Class I) to highest (Class III), which determines how much regulatory scrutiny they face.

Class IIa

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Tooth Whitening System

Additional information URL

https://www.ultradent.eu/products/categories/whitening/medical-tooth-whitening/opalescence-quick-pf?sku=5346-

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q010199CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER

• Class IIa medical devices in EUDAMED

No certificate specifically references this device's Basic UDI-DI.