Organization name

World Class Technology Corporation

SRN

US-MF-000014389

Manufacturer status

Active

2 warnings recorded — scroll inside the panel to see all entries.

• CW027

  The Pitts21® PRO system is MR unsafe. When scheduling an MRI or other radiology services while wearing orthodontic appliances, always inform MRI or other radiology staff prior to the procedure so that proper coordination of care can be arranged. The Pitts21® PRO system has not been evaluated for safety and compatibility in the MR environment. It has not been tested for heating, migration, or image artifacts in the MR environment. Scanning a patient who has this device may result in patient injury, unintended bracket movement or detachment.
• CW999

  • Patient’s inability or unwillingness to cooperate/or follow the treatment plan. • Patient with deficient oral hygiene. • Known allergies to any of the components or materials in the system. • Any illness and/or underlying conditions that preclude orthodontic treatment. • Any existing tooth root resorption. • Any existing decalcification of the tooth enamel.

Primary placement in Poland; available across 22 countries total.

Trade name

Pitts21® PRO

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.

00840273900207

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.

B-00840273900207

Reference / catalog number

956.2021-10

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

MDD [Directive 93/42/EEC on medical devices]

Status

On the market

Quantity

1

Additional product description

—

Additional information URL

No additional information URL provided by the manufacturer.

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.

• Q010403ORTHODONTIC BRACKETS AND BUTTONS

• Class IIa medical devices in EUDAMED

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