Organization name

Ultradent Products, Inc.

SRN

US-MF-000013697

Manufacturer status

Active

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

• CW999

  CAUTION UV emitted from this product. Eye or skin irritation may result from exposure. Use appropriate shielding. CAUTION Possibly hazardous optical radiation emitted from this product. Do not stare at operating lamp. May be harmful to the eyes. DO NOT look directly into the light output. Patient, clinician, and assistants should always wear amber colored UV eye protection when curing light is in use. To prevent the risk of electric shock, no modification of this equipment is allowed. Use only the included Ultradent VALO power supply and plug adapters. If these components are damaged, do not use and call Ultradent Customer Service to order a replacement. Use only authorized accessories, cables, and power supplies to prevent improper operation, increased electromagnetic emissions or decreased electromagnetic immunity (refer to Electromagnetic Emissions section) To avoid the risk of electrical fire associated with handling of batteries: DO NOT mix rechargeable batteries with non-rechargeable batteries or other battery types. DO NOT attempt to charge non-rechargeable batteries. DO NOT autoclave or spray batteries, battery contacts, charger, or AC power adapter with liquid of any kind. If corrosion appears on the contacts of the battery charger, call Ultradent Customer Service to order a replacement. DO NOT charge batteries around flammable materials. DO NOT keep charger in clinical operatory. To prevent the risk of thermal irritation or injury, avoid back-to-back curing cycles and do not expose oral soft tissues at close proximity for more than 10 seconds in any mode. If longer curing times are required, use multiple shorter curing cycles or use a dual-cure product to avoid heating soft tissue.

Primary placement in Germany; available across 28 countries total.

Trade name

VALO Grand Red Rock (Cordless)

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.

00883205030917

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-TF086BF

Reference / catalog number

4865

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 I

Applicable legislation

MDR [Regulation (EU) 2017/745 on medical devices]

Status

On the market

Quantity

1

Additional product description

Curing Light

Additional information URL

https://www.ultradent.eu/products/categories/equipment/curing-lights/valo-grand?sku=4865-

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.

• Z12119003COLD LIGHT DENTAL EQUIPMENT

• Class I medical devices in EUDAMED

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