Identity
- Trade Name
- RISKONTROL LU INOX EUDAMEDADAPTATER RISKONTROL LU INOX FDA UDI
- Generic Name
- Dental delivery system irrigation handpiece FDA UDI
- Device Name
- RISKONTROL adapter EUDAMEDThe RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes. FDA UDI
- Model / Reference
- 200150 EUDAMEDRISKONTROL FDA UDI
- Description
- The RISKONTROL adapter allows the use of the RISKONTROL disposable tips onto the air/water syringes. FDA UDI
Identifiers
- Catalog Number
- 200150 FDA UDI
- Primary DI / UDI-DI
- 03760243000263 EUDAMEDFDA UDI
- Basic UDI-DI
- 376024300adaptateurTU EUDAMED
- FDA Product Code
- ECB FDA UDI
- EMDN Code
- Q0199 ODONTOLOGY DEVICES - OTHER EUDAMED
- GMDN Term
- Dental delivery system irrigation handpiece FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.4565 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Riskontrol Lu Inox by Acteon Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 376024300adaptateurTU | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED 709334e5-0d04-471d-a81e-01ba2c33a462 61 fields · synced Jun 19, 2026
- FDA UDI 153e0641-a639-4140-ba7e-1b14d3eb395b 35 fields · synced May 30, 2026