Grandio SO

FDA UDI

Class II (US FDA UDI)

by VOCO GmbH

Identity

Trade Name: Grandio SO FDA UDI
Generic Name: Dentine adhesive FDA UDI
Device Name: Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide. FDA UDI
Model / Reference: 2601 FDA UDI
Description: Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide. FDA UDI

Identifiers

Catalog Number: 2601 FDA UDI
Primary DI / UDI-DI: E22126011 FDA UDI
FDA Product Code: KLE FDA UDI
EBF FDA UDI
GMDN Term: Dentine adhesive FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 872.3200 FDA UDI
872.3690 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

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Dental composite resin Dentine adhesive

Grandio SO by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: VOCO GmbH

Sources (1)

FDA UDI 28959686-eaa6-47fc-81f8-81468e782ef8 36 fields · synced May 30, 2026