Organization name

DENTCA, Inc.

SRN

US-MF-000007372

Manufacturer status

Active

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

• CW999

  1. DENTCA Denture Base II contains polymerizable monomers which may cause skin irritation (allergic contact dermatitis) or other allergic reactions in susceptible persons. If contact with skin, wash thoroughly with soap and water. If skin sensitization occurs, discontinue use. If dermatitis or other symptoms persist, seek medical assistance. 2. Avoid inhalation or ingestion. High vapor concentration can cause headache, irritation of eyes or respiratory system. Direct contact with eyes may cause possible corneal damage. Long-term excessive exposure to the material may cause more serious health effects. Specifically, it is not suitable for pregnant or breastfeeding women. Monitor air quality per OSHA standards. Eye Contact: Immediately flush eyes with plenty of clean water for at least 20 minutes, and consult a physician. Wash the contacted area thoroughly with soap and water. Inhalation: In case of exposure to a high concentration of vapor or mist, remove person to fresh air. Give oxygen or artificial respiration as required. Ingestion: Contact your regional poison control center immediately. BURN HAZARD: GLYCEROL BATH CAN REACH TEMPERATURES OF 90 oC (~200 oF) AND LEAD TO SEVERE BURNS. Only trained users should perform the glycerol curing step with caution and appropriate PPE. We also recommend placing a warning label on the window of the cure unit to alert all lab users to the potential hazard.
• CW999

  1. Direct contact with the uncured resin may induce skin sensitization in susceptible individuals. 2. Proper ventilation and personal protective equipment should be used when grinding denture base resins as the particulate generated during grinding may cause respiratory, skin or eye irritation.

Primary placement in Germany; available across 32 countries total.

Trade name

DENTCA Denture Base II

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.

00856551007278

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-00856551007278

Reference / catalog number

01304

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

• 1 MU29

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

European Medical Device Nomenclature — the EU product classification assigned to this device.

• Q0102050102DENTAL REBASING RESINS

• Class IIa medical devices in EUDAMED

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