Identity
- Trade Name
- EASE-IT FDA UDI
- Generic Name
- Dental material heater FDA UDI
- Device Name
- Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials. FDA UDI
- Model / Reference
- 20020 FDA UDI
- Description
- Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05713513001000 FDA UDI
- FDA Product Code
- EEG FDA UDI
- GMDN Term
- Dental material heater FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 872.6475 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental material heater
Ease-It by Rønvig Dental Manufacturing A/S — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Rønvig Dental Manufacturing A/S
Sources (1)
- FDA UDI 5a9e8d81-f70d-45c8-8361-d040db3c3ed0 33 fields · synced Jun 8, 2026