Identity
- Trade Name
- CICADA FDA UDI
- Generic Name
- Endodontic plugger FDA UDI
- Device Name
- Obturation Pen EUDAMEDGutta Cutter FDA UDI
- Model / Reference
- CV-Fill-P1 EUDAMEDFDA UDI
- Description
- Gutta Cutter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06974456210617 EUDAMEDFDA UDI
- Basic UDI-DI
- 697445621CV-Fill-P1UL EUDAMED
- FDA Product Code
- EKM FDA UDI
- EMDN Code
- L159099 ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Endodontic plugger FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 872.3850 FDA UDI
- Market of Registration
- Spain 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
No
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
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Obturation Pen by Foshan CICADA Dental Instrument Co., Ltd. — 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 | 697445621CV-Fill-P1UL | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Foshan Cicada Dental Instrument Co., Ltd
- EUDAMED SRN
- CN-MF-000001167
- Authorised Representative
- Lotus NL B.V. NL-AR-000000121
Sources (2)
- EUDAMED 615708c4-6e88-4e93-91b2-24f8c85fd60c 61 fields · synced Jun 19, 2026
- FDA UDI fb43aade-2627-42e6-b218-8b043e69320a 33 fields · synced May 30, 2026