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Grandio SO Heavy Flow

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref 2695

by VOCO GmbH

Identity

Trade Name
GrandioSO Heavy Flow EUDAMED
Grandio SO Heavy Flow FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
GrandioSO Heavy Flow EUDAMED
Flowable universal nano-hybrid restorative material - highly viscous FDA UDI
Model / Reference
2695 EUDAMEDFDA UDI
Description
Flowable universal nano-hybrid restorative material - highly viscous FDA UDI

Identifiers

Catalog Number
2695 FDA UDI
Primary DI / UDI-DI
E22126951 EUDAMEDFDA UDI
Basic UDI-DI
++E2210156000000000DF EUDAMED
510(k) Number
K102354 FDA UDI
FDA Product Code
EBF FDA UDI
EMDN Code
Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
GMDN Term
Dental composite resin FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class II FDA UDI
Regulation Number
872.3690 FDA UDI
Market of Registration
Germany EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

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

Cleared under the same submission

K102354 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
VOCO GmbH

Sources (2)

  • FDA UDI 8014db31-3e03-4149-846a-7a8ca6d1c1c5 37 fields · synced Oct 7, 2026
  • EUDAMED f7a9dfcd-c6c8-49cd-bc37-bb05cc8d298e 61 fields · synced Jul 24, 2026