Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

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

• CW999

  Resins can be sensitizing. Avoid repeated contact of uncured dental resin with skin. If contact occurs, thoroughly rinse skin. Do not use on patients with a known sensitivity to acrylates or other resins. If allergic reaction, dermatitis, or rash develops have patient consult their physician.

Primary placement in Germany; available across 28 countries total.

Trade name

UltraSeal XT hydro

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.

00883205104175

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-TF018AW

Reference / catalog number

3534

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

Light Curable Pit and Fissure Sealant

Additional information URL

https://www.ultradent.eu/products/categories/prevent-hygiene/sealants/ultraseal-xt-hydro?sku=3534

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.