Identity
- Trade Name
- EXPASYL x20 FDA UDI
- Generic Name
- Gingival retraction kit FDA UDI
- Device Name
- Sulcular opening paste (x20 capsules). FDA UDI
- Model / Reference
- EXPASYL FDA UDI
- Description
- Sulcular opening paste (x20 capsules). FDA UDI
Identifiers
- Catalog Number
- 261030 FDA UDI
- Primary DI / UDI-DI
- 03760243000706 FDA UDI
- 510(k) Number
- K050180 FDA UDI
- FDA Product Code
- MVL FDA UDI
- GMDN Term
- Gingival retraction kit FDA UDI
Classification
- Device Class
- U 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
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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Gingival retraction kit
EXPASYL x20 by Acteon Manufacturing — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
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 U | Pending data |
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Manufacturer
- Manufacturer
- Acteon Manufacturing
Sources (1)
- FDA UDI 21a2ce99-2620-4309-8afd-ae1cf46b0099 37 fields · synced Jun 8, 2026