Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

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

• CW999

  Hydrofluoric acid gives off a vapor that irritates respiratory passageways and on a chronic basis can cause damage. Ultradent Porcelain Etch is buffered, gelled, and dispensed in a way that minimizes these problems. Instructions must be followed to ensure complete removal of any harmful material. Silane is applied after etching in preparation for bonding resin. If proper precautions are followed, porcelain may be safely etched intraorally for bonding. If etchants contact any soft tissue, IMMEDIATELY rinse area with copious amounts of water. If the product is ingested, drink large amounts of water and contact a physician. If the product is aspirated, seek immediate medical attention.

Primary placement in Germany; available across 28 countries total.

Trade name

Porcelain Etch

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.

00883205103642

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-TF052AW

Reference / catalog number

406

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

9% Buffered Hydrofluoric Acid

Additional information URL

https://www.ultradent.eu/products/categories/bond-etch/etchants/porcelain-etch-silane

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.

• Q01010402ENAMEL-DENTINAL ETCHING MATERIALS

• Class IIa medical devices in EUDAMED

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