Viscogel

FDA UDI

Class II (US FDA UDI)

by Dentsply De Trey GmbH

Identity

Trade Name: VISCOGEL FDA UDI
Generic Name: Denture reliner, soft, professional FDA UDI
Device Name: VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit. FDA UDI
Model / Reference: 61605002 FDA UDI
Description: VISCO GEL Standard Pack is a self-curing, resilient methacrylate formulation, intended for use as a limited-term soft linig material for complet and partial dentures. Visco-gel is received in 2 components powder (D010K2006000) and liquid (D010K3006010) both of them in a bottle delivery. With an additional bottle of a separator (D010K3006020) and its supporting accessories (Mixing Bowl, Powder Measure and Liquid Measure) it can be classified as a convenience kit. FDA UDI

Identifiers

Catalog Number: 61605002 FDA UDI
Primary DI / UDI-DI: D010616050021 FDA UDI
FDA Product Code: EBI FDA UDI
GMDN Term: Denture reliner, soft, professional FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3760 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

Yes

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Weight — 120 Gram FDA UDI
Total Volume — 15 Milliliter FDA UDI
Total Volume — 90 Milliliter FDA UDI

Category: Denture reliner, soft, professional

Viscogel by Dentsply De Trey GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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FLEXACRYL — Lang Dental Manufacturing Company, Inc. · Class II

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 II	Pending data

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Manufacturer

Manufacturer: Dentsply De Trey GmbH

Sources (1)

FDA UDI 806c6f3d-e4cc-47fd-9617-ab7ee8c1a83a 36 fields · synced May 30, 2026