Identity
- Trade Name
- Expasyl Canules/cannulas EUDAMEDExpasyl cannulas FDA UDI
- Generic Name
- Dental material injection cannula, single-use FDA UDI
- Device Name
- Expasyl Canules/cannulas EUDAMEDExpasyl bended application cannulas x40 for EXPASYL paste (sulcular opening paste). FDA UDI
- Model / Reference
- 261045 EUDAMED294028 EUDAMEDEXPASYL FDA UDI
- Description
- Expasyl bended application cannulas x40 for EXPASYL paste (sulcular opening paste). FDA UDI
Identifiers
- Catalog Number
- 261045 FDA UDI
- Primary DI / UDI-DI
- 03760243000744 EUDAMEDFDA UDI03760243000768 EUDAMED
- Basic UDI-DI
- 376024300expacanule7H EUDAMED
- Unit of Use DI
- 03760243009839 EUDAMED
- 510(k) Number
- K050180 FDA UDI
- FDA Product Code
- MVL FDA UDI
- EMDN Code
- Q010204 RETRACTION WIRES AND GINGIVAL RETRACTORS EUDAMED
- GMDN Term
- Dental material injection cannula, single-use FDA UDI
Classification
- Device Class
- Class I EUDAMEDU FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
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
Category: Gingival retraction cord, non-medicated
Expasyl Canules/cannulas by Acteon Manufacturing — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Also classified as Gingival retraction cord, non-medicated.
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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 | 376024300expacanule7H | 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 (3)
- EUDAMED 604cebb6-fc8f-4790-921d-100bb3dd3b5e 61 fields · synced Jul 15, 2026
- EUDAMED 71c35eb7-f0f0-4a78-b8c7-7645befdf4f2 61 fields · synced May 19, 2026
- FDA UDI 99eab742-5025-4ffc-9571-aa03cb91db5f 36 fields · synced May 29, 2026