EXPASYL x6

FDA UDIEUDAMED

Class U (US FDA UDI)

by Acteon Manufacturing

Identity

Trade Name: EXPASYL x6 FDA UDI
Generic Name: Gingival retraction kit FDA UDI
Device Name: Sulcular opening paste (x6 capsules). FDA UDI
Model / Reference: EXPASYL FDA UDI
Description: Sulcular opening paste (x6 capsules). FDA UDI

Identifiers

Catalog Number: 294010 FDA UDI
Primary DI / UDI-DI: 03760243005008 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

FDA UDI

Single Use

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Gingival retraction kit

EXPASYL x6 by Acteon Manufacturing — Class U — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

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Cleared under the same submission

K050180 also covers:

ACTEON — ACTEON MANUFACTURING
EXPASYL strawberry flavor — ACTEON MANUFACTURING
EXPASYL x20 — ACTEON MANUFACTURING
Henry Schein — HENRY SCHEIN, INC.
Henry Schein — HENRY SCHEIN, INC.
Henry Schein — HENRY SCHEIN, INC.
Henry Schein — HENRY SCHEIN, INC.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDR	—	Class U	Unknown
FDA UDI	United States	FDA UDI	Registered in GUDID	Class U	Pending data

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Manufacturer

Manufacturer: Acteon Manufacturing

Sources (2)

FDA UDI bba98e8c-f0fb-467d-8047-3157edf550cc 37 fields · synced Jun 18, 2026
EUDAMED 1 fields · synced Jun 3, 2026