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GrandioSO Light Flow

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 2585510(k) K200294Ref 2612Ref 2661Ref 2621Ref 2648Ref 2654Ref 2620Ref 2616Ref 2588Ref 2659Ref 2589Ref 2635Ref 2675Ref 2619Ref 2629Ref 2627Ref 2640Ref 2671Ref 2669Ref 2664Ref 2590Ref 2614Ref 2613

by VOCO GmbH

Identity

Trade Name
GrandioSO Light Flow EUDAMEDFDA UDI
GrandioSO EUDAMED
Grandio SO FDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
GrandioSO Light Flow EUDAMED
GrandioSO EUDAMED
Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide. FDA UDI
Universal nano-hybrid restorative material FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material The set contains 5 different shades of GrandioSOFlow, a shade guide and application cannulas type 44 and type 45. FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3.5 FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3 FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour WO FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour B1 FDA UDI
Model / Reference
2585 EUDAMEDFDA UDI
2640 EUDAMEDFDA UDI
2616 EUDAMEDFDA UDI
2589 EUDAMEDFDA UDI
2614 EUDAMEDFDA UDI
2588 EUDAMEDFDA UDI
2654 EUDAMEDFDA UDI
2619 EUDAMEDFDA UDI
2659 EUDAMEDFDA UDI
2635 EUDAMEDFDA UDI
2613 EUDAMEDFDA UDI
2627 EUDAMEDFDA UDI
2664 EUDAMEDFDA UDI
2590 EUDAMEDFDA UDI
2629 EUDAMEDFDA UDI
2621 EUDAMEDFDA UDI
2620 EUDAMEDFDA UDI
2669 EUDAMEDFDA UDI
2671 EUDAMEDFDA UDI
2661 EUDAMEDFDA UDI
2675 EUDAMEDFDA UDI
2612 EUDAMEDFDA UDI
2648 EUDAMEDFDA UDI
2631 FDA UDI
2591 FDA UDI
2673 FDA UDI
2624 FDA UDI
2630 FDA UDI
Description
Universal nano-hybrid restorative material. The kit contains different shades of Grandio SO and a shade guide. FDA UDI
Universal nano-hybrid restorative material FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material The set contains 5 different shades of GrandioSOFlow, a shade guide and application cannulas type 44 and type 45. FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3.5 FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour A3 FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour WO FDA UDI
highly flowable, light-curing, radiopaque nano-hybrid restorative material, colour B1 FDA UDI

Identifiers

Catalog Number
2640 FDA UDI
2616 FDA UDI
2631 FDA UDI
2585 FDA UDI
2589 FDA UDI
2614 FDA UDI
2588 FDA UDI
2591 FDA UDI
2654 FDA UDI
2619 FDA UDI
2659 FDA UDI
2635 FDA UDI
2613 FDA UDI
2627 FDA UDI
2664 FDA UDI
2590 FDA UDI
2629 FDA UDI
2621 FDA UDI
2620 FDA UDI
2673 FDA UDI
2669 FDA UDI
2671 FDA UDI
2661 FDA UDI
2624 FDA UDI
2675 FDA UDI
2612 FDA UDI
2648 FDA UDI
2630 FDA UDI
Primary DI / UDI-DI
E22125851 EUDAMEDFDA UDI
E22126401 EUDAMEDFDA UDI
E22126161 EUDAMEDFDA UDI
E22125891 EUDAMEDFDA UDI
E22126141 EUDAMEDFDA UDI
E22125881 EUDAMEDFDA UDI
E22126541 EUDAMEDFDA UDI
E22126191 EUDAMEDFDA UDI
E22126591 EUDAMEDFDA UDI
E22126351 EUDAMEDFDA UDI
E22126131 EUDAMEDFDA UDI
E22126271 EUDAMEDFDA UDI
E22126641 EUDAMEDFDA UDI
E22125901 EUDAMEDFDA UDI
E22126291 EUDAMEDFDA UDI
E22126211 EUDAMEDFDA UDI
E22126201 EUDAMEDFDA UDI
E22126691 EUDAMEDFDA UDI
E22126711 EUDAMEDFDA UDI
E22126611 EUDAMEDFDA UDI
E22126751 EUDAMEDFDA UDI
E22126121 EUDAMEDFDA UDI
E22126481 EUDAMEDFDA UDI
E22126311 FDA UDI
E22125911 FDA UDI
E22126731 FDA UDI
E22126241 FDA UDI
E22126301 FDA UDI
Basic UDI-DI
++E2210159000000000G6 EUDAMED
++E2210155000000000CJ EUDAMED
510(k) Number
K102351 FDA UDI
K200294 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 UDIFDA 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

Yes

FDA UDIFDA 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: Dental composite resin

GrandioSO Light Flow by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS

Similar devices

Also classified as Dental composite resin.

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

European Union Active

CE/MDR

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
VOCO GmbH
EUDAMED SRN
DE-MF-000008601

Sources (52)

  • EUDAMED f33123a2-d88d-4ccd-8fea-c30d07ff43ac 85 fields · synced Oct 6, 2026
  • FDA UDI cec25230-8685-4be6-b0be-3558c7ebdffd 37 fields · synced May 27, 2026
  • FDA UDI de2dc950-8f55-4f08-9c9c-57e7d4c469f8 37 fields · synced May 27, 2026
  • FDA UDI 93cb68d4-b273-4d7b-93f7-1f52ac4ff34b 37 fields · synced May 30, 2026
  • FDA UDI 89b39789-a096-40f8-ac52-fe9a5c66d90a 37 fields · synced May 30, 2026
  • FDA UDI bb63c9d4-cb5b-45c9-9f79-32a2eb933626 37 fields · synced May 30, 2026
  • FDA UDI 55505e7a-c790-4b40-8235-e0d48e5d5e19 37 fields · synced May 30, 2026
  • FDA UDI 5a97aa32-0901-4d75-bf17-66cdbe7ae9de 37 fields · synced May 30, 2026
  • FDA UDI 5759ef71-d434-48ce-b103-efb3916545d0 37 fields · synced May 30, 2026
  • FDA UDI 0a65d2d7-5618-4db8-b318-1b24464c1889 37 fields · synced May 30, 2026
  • FDA UDI a6d21eee-500e-486f-bd87-3f22ea79201b 37 fields · synced May 30, 2026
  • FDA UDI 9950438b-4faf-46f3-b0e8-4be6288e04ee 37 fields · synced May 30, 2026
  • FDA UDI 2fca80b2-dd12-4a1a-bb93-5ad60e811b90 37 fields · synced May 30, 2026
  • FDA UDI 40564775-2238-4d29-a9b9-596cc1a72332 37 fields · synced May 30, 2026
  • FDA UDI b7a784aa-3e3f-4f79-996e-4289bcdabcd6 37 fields · synced May 30, 2026
  • FDA UDI ceac0569-0e7a-4385-8003-6cfe02849c92 37 fields · synced May 30, 2026
  • FDA UDI 1e03d0d3-e31d-478c-b556-20e220b3ab4b 37 fields · synced May 30, 2026
  • FDA UDI 5c52a2d3-33cc-49fd-904c-95df33530575 37 fields · synced May 30, 2026
  • FDA UDI 7814580a-f5df-48e4-9608-17d8ae589f9d 37 fields · synced May 30, 2026
  • FDA UDI 99e3f966-24dd-4410-a51f-4375b64f3551 37 fields · synced May 30, 2026
  • FDA UDI bc110114-da0b-4971-b98c-cc81a39be018 37 fields · synced May 30, 2026
  • FDA UDI 8c31b46b-ddf4-44a3-9919-d5dbe039955a 37 fields · synced May 30, 2026
  • FDA UDI 17b819cb-562f-4532-a877-975e8f998ab7 37 fields · synced May 30, 2026
  • FDA UDI 14cdd3fa-1089-43c3-9a18-edee875dade3 37 fields · synced May 30, 2026
  • FDA UDI daebb148-f7f3-42bb-a5b4-235255a671e3 37 fields · synced May 30, 2026
  • FDA UDI 3163827f-2eec-4494-8780-a75db69daa50 37 fields · synced May 30, 2026
  • FDA UDI cd06a90a-66df-4171-8155-2ac6bfedff48 37 fields · synced May 30, 2026
  • FDA UDI 40b87401-71f9-49eb-9a08-9abbad713c2f 37 fields · synced May 30, 2026
  • FDA UDI 25a22e62-3874-4879-b712-b771daf7b45e 37 fields · synced May 30, 2026
  • EUDAMED 0623c2c5-829b-4010-b81e-26aae7172935 61 fields · synced Jul 8, 2026
  • EUDAMED 692879dc-59d2-4a89-be2b-98ebf4464200 61 fields · synced Jul 9, 2026
  • EUDAMED f985b263-0e41-4797-8c22-75321925f872 61 fields · synced Jul 9, 2026
  • EUDAMED 6acdf143-3034-4ac0-bc69-0c497853d15d 61 fields · synced Jul 9, 2026
  • EUDAMED 4ef4d39c-793c-4e63-ae78-d373e950b1bc 61 fields · synced Jul 9, 2026
  • EUDAMED 62cf72b5-4839-4d63-aeec-ff925ce75f37 61 fields · synced Jul 9, 2026
  • EUDAMED 981a878f-ffac-4c4c-bf9e-a15e2c2958e0 61 fields · synced Jul 10, 2026
  • EUDAMED b20b9b35-00dd-41bf-9074-33b6f992b853 61 fields · synced Jul 11, 2026
  • EUDAMED 987e3e6e-6c95-48a0-9520-eda91a118015 61 fields · synced Jul 12, 2026
  • EUDAMED 3615ff8c-0aa3-4690-bd12-15be5d93c352 61 fields · synced Jul 13, 2026
  • EUDAMED dfdc4708-5fc8-4ce9-9326-60dfc1135bb8 61 fields · synced Jul 13, 2026
  • EUDAMED 7b7a29de-c556-468f-b6a5-15cd653186a8 61 fields · synced Jul 13, 2026
  • EUDAMED f1224f5c-9076-4863-a2db-a814cce1c895 61 fields · synced Jul 13, 2026
  • EUDAMED 0bf1ef6e-f0ac-48ea-85b0-e352120dde19 61 fields · synced Jul 13, 2026
  • EUDAMED b4fb2f18-0fde-4ed4-85d4-7a266cc932ed 61 fields · synced Jul 13, 2026
  • EUDAMED 65acc91e-3d4e-4e38-84e9-8d06d2cea2ba 61 fields · synced Jul 15, 2026
  • EUDAMED 264fbc48-6d03-496f-aed9-459a915b4183 61 fields · synced Jul 16, 2026
  • EUDAMED aeb66aef-8e0a-4d3d-92d4-61b9384c776c 61 fields · synced Jul 20, 2026
  • EUDAMED 1fdf9711-a990-451d-8e9f-eb7d0ab834eb 61 fields · synced Jul 22, 2026
  • EUDAMED a3599e93-09e3-4684-aa18-de74b2a0aa83 61 fields · synced Jul 23, 2026
  • EUDAMED ac5924cb-8b93-4cd9-aae1-8f9fd4517657 61 fields · synced Jul 23, 2026
  • EUDAMED 935e7aec-f8e5-4eac-b9c1-3988a124dbfa 61 fields · synced Jul 24, 2026
  • FDA 510(k) K200294 1 fields · synced May 18, 2026