Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

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

• CW999

  Do not use on patients with a known sensitivity to ingredients including colophony (kolophonium) and/rosin. If allergic reaction, dermatitis, or rash develops, consult a physician. In rare instances, edematous swelling has been reported after extensive fluoride varnish treatment and dyspnea has been reported in asthmatic children. If this occurs, thoroughly brush teeth to remove the varnish film and have patient contact their medical provider.

Primary placement in Germany; available across 28 countries total.

Trade name

Enamelast

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.

00883205102836

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-TF327BE

Reference / catalog number

4353

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

5% Sodium Fluoride

Additional information URL

https://www.ultradent.eu/products/categories/prevent-hygiene/fluoride/enamelast?sku=4353-

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.