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 straight application cannulas x40 for EXPASYL paste (sulcular opening paste). FDA UDI
- Model / Reference
- 261040 EUDAMEDEXPASYL FDA UDI
- Description
- Expasyl straight application cannulas x40 for EXPASYL paste (sulcular opening paste). FDA UDI
Identifiers
- Catalog Number
- 261040 FDA UDI
- Primary DI / UDI-DI
- 03760243000720 EUDAMEDFDA UDI
- Basic UDI-DI
- 376024300expacanule7H EUDAMED
- Unit of Use DI
- 03760243009822 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
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
Yes
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
Similar devices
Also classified as Gingival retraction cord, non-medicated.
- R-101 — PASCAL COMPANY, INC. · Class I
- Smartcord 2 — EASTDENT Co., Ltd · Class I
- roeko Retracto / braided / non-impregnated, x-fine (0), 225 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- Hilo de retracción tejido Nº2 Dentaflux — J RIPOLL SL · Class I
- Hilo de retracción tejido Nº00 Dentaflux — J RIPOLL SL · Class I
- Henry Schein — HENRY SCHEIN, INC. · U
- roeko Stay-put / non-impregnated, x-fine (0), 183 cm — Coltène/Whaledent GmbH + Co. KG · Class I
- G-DENT Retraction Cord N.000 — UAB "Medicinos linija" · Class I
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Acteon Manufacturing
- EUDAMED SRN
- FR-MF-000007556
Sources (2)
- EUDAMED 618b7bcd-fa6e-4fbe-93c6-b89c4476f3df 61 fields · synced Jun 17, 2026
- FDA UDI a88ecc8c-e9b1-4a6c-a7e2-a65830aee328 36 fields · synced May 30, 2026