Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

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

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

• UltraCal XS paste can cause permanent paralysis when expressed into the inferior alveolar canal space. Proceed with caution when using UltraCal XS paste close to this anatomical area. Take extra precaution to avoid UltraCal XS paste extrusion when working in locations with sensitive anatomical proximities—such as the inferior alveolar canal, mental foramen, maxillary sinuses, etc. Take extra precaution to avoid UltraCal XS paste extrusion when identifying root anatomical changes—such as root resorptions, wide opening foramen, incomplete root constriction, etc. Monitor very closely the amount of UltraCal XS paste dispensed inside each canal to prevent overfilling of the canal. Only a very small amount of UltraCal XS paste is needed to fill a canal. If a small puff is noticed on the periapical X-ray, this quantity is usually tolerated very well by the surrounding tissue. However, UltraCal XS paste has a neurotoxic effect on the nerve. If UltraCal XS paste is expressed into the mandibular canal or maxillary sinus cavity, immediately refer to an oral surgeon for evaluation. Avoid contact with skin, eyes, oral mucosa, soft tissue, etc., as UltraCal XS paste has a very high pH and can cause burns. In cases of contact, rinse immediately with copious amounts of water and seek proper medical attention. If swallowed: immediately rinse out mouth, then drink copious amounts of water, and seek proper medical attention

  OTHER

Primary placement in Germany; available across 28 countries total.

Trade name

UltraCal XS

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.

00883205039149

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-TF017AU

Reference / catalog number

5145-CE

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

Calcium Hydroxide Paste

Additional information URL

https://www.ultradent.eu/products/categories/endodontics/irrigants-lubricants-medicaments/ultracal-xs

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.

• Q01010201ROOT CANAL FILLING DENTAL PASTES

• Class IIa medical devices in EUDAMED