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Grandio Flow Try-In

FDA 510(k)FDA UDIEUDAMED

Class II (US FDA 510(k))

510(k) K062343Ref 1808Ref 1819Ref 1883Ref 1823Ref 1863Ref 1816Ref 1846Ref 1822Ref 1867Ref 1801Ref 1880Ref 1871Ref 1845Ref 1854Ref 1825Ref 1840Ref 1870Ref 1813Ref 1820

by VOCO GmbH

Identity

Trade Name
Grandio EUDAMEDFDA UDI
Grandio Flow EUDAMEDFDA UDI
Generic Name
Dental composite resin FDA UDI
Device Name
Grandio EUDAMED
Grandio Flow EUDAMED
Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material. FDA UDI
Flowable universal nano-hybrid restorative material FDA UDI
Flowable universal nano-hybrid material FDA UDI
Universal nano-hybrid restorative material. FDA UDI
Model / Reference
1816 EUDAMEDFDA UDI
1820 EUDAMEDFDA UDI
1845 EUDAMEDFDA UDI
1823 EUDAMEDFDA UDI
1867 EUDAMEDFDA UDI
1854 EUDAMEDFDA UDI
1870 EUDAMEDFDA UDI
1819 EUDAMEDFDA UDI
1871 EUDAMEDFDA UDI
1813 EUDAMEDFDA UDI
1808 EUDAMEDFDA UDI
1883 EUDAMEDFDA UDI
1846 EUDAMEDFDA UDI
1880 EUDAMEDFDA UDI
1863 EUDAMEDFDA UDI
1822 EUDAMEDFDA UDI
1825 EUDAMEDFDA UDI
1840 EUDAMEDFDA UDI
1801 EUDAMED
1847 FDA UDI
1817 FDA UDI
1841 FDA UDI
1868 FDA UDI
1851 FDA UDI
1876 FDA UDI
1810 FDA UDI
1811 FDA UDI
1842 FDA UDI
1818 FDA UDI
1855 FDA UDI
1852 FDA UDI
1849 FDA UDI
Description
Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material. FDA UDI
Flowable universal nano-hybrid restorative material FDA UDI
Flowable universal nano-hybrid material FDA UDI
Universal nano-hybrid restorative material. FDA UDI

Identifiers

Catalog Number
1847 FDA UDI
1817 FDA UDI
1841 FDA UDI
1816 FDA UDI
1820 FDA UDI
1845 FDA UDI
1823 FDA UDI
1868 FDA UDI
1851 FDA UDI
1867 FDA UDI
1876 FDA UDI
1854 FDA UDI
1810 FDA UDI
1870 FDA UDI
1819 FDA UDI
1871 FDA UDI
1813 FDA UDI
1808 FDA UDI
1811 FDA UDI
1883 FDA UDI
1842 FDA UDI
1818 FDA UDI
1846 FDA UDI
1880 FDA UDI
1863 FDA UDI
1822 FDA UDI
1855 FDA UDI
1852 FDA UDI
1825 FDA UDI
1849 FDA UDI
1840 FDA UDI
Primary DI / UDI-DI
E22118161 EUDAMEDFDA UDI
E22118201 EUDAMEDFDA UDI
E22118451 EUDAMEDFDA UDI
E22118231 EUDAMEDFDA UDI
E22118671 EUDAMEDFDA UDI
E22118541 EUDAMEDFDA UDI
E22118701 EUDAMEDFDA UDI
E22118191 EUDAMEDFDA UDI
E22118711 EUDAMEDFDA UDI
E22118131 EUDAMEDFDA UDI
E22118081 EUDAMEDFDA UDI
E22118831 EUDAMEDFDA UDI
E22118461 EUDAMEDFDA UDI
E22118801 EUDAMEDFDA UDI
E22118631 EUDAMEDFDA UDI
E22118221 EUDAMEDFDA UDI
E22118251 EUDAMEDFDA UDI
E22118401 EUDAMEDFDA UDI
E22118011 EUDAMED
E22118471 FDA UDI
E22118171 FDA UDI
E22118411 FDA UDI
E22118681 FDA UDI
E22118511 FDA UDI
E22118761 FDA UDI
E22118101 FDA UDI
E22118111 FDA UDI
E22118421 FDA UDI
E22118181 FDA UDI
E22118551 FDA UDI
E22118521 FDA UDI
E22118491 FDA UDI
Basic UDI-DI
++E2210162000000000AS EUDAMED
++E2210164000000000CL EUDAMED
510(k) Number
K062343 FDA 510(k)
K051867 FDA UDI
FDA Product Code
EBF FDA 510(k)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 510(k)FDA UDI
Legislation / Framework
21 CFR Part 872.3690 FDA 510(k)
Regulation Number
872.3690 FDA 510(k)FDA UDI
Market of Registration
Germany EUDAMED
Advisory Committee
Dental FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
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

The Grandio Flow Try-In is a dental composite resin designed for temporary restorations and try-in procedures. It provides a reliable, aesthetic solution for dentists to evaluate fit, occlusion, and appearance of restorations before permanent placement, ensuring patient satisfaction and clinical accuracy.

Supplied as a single-use, radiopaque material, the Grandio Flow Try-In is intended for use in dental offices under aseptic conditions. It is compatible with standard dental equipment and adheres to FDA 510(k) clearance (K062343) and MDR requirements. The product is packaged in individual units for sterile application, with no specific MRI safety restrictions noted.

Frequently asked questions

What is the Grandio Flow Try-In used for in a dental setting?

The Grandio Flow Try-In is specifically designed for temporary restorations and try-in procedures in dentistry. It allows dentists to assess the fit, occlusion (bite alignment), and aesthetic appearance of a restoration before permanently placing it. This helps ensure the final result meets both clinical and patient satisfaction standards.

Is the Grandio Flow Try-In single-use or reusable, and how is it packaged?

The Grandio Flow Try-In is supplied as a single-use product, packaged in individual sterile units. This ensures aseptic conditions during application in dental offices, reducing the risk of contamination and cross-infection.

Can this material be used with standard dental equipment, and does it have any special safety considerations?

Yes, the Grandio Flow Try-In is compatible with standard dental equipment. It is radiopaque, meaning it can be visualized on X-rays, which is useful for diagnostic purposes. There are no specific MRI safety restrictions mentioned, so it can be used without concern in that context.

How is the regulatory status of the Grandio Flow Try-In defined, and what does that mean for users?

The Grandio Flow Try-In holds FDA 510(k) clearance (K062343) and complies with MDR (Medical Device Regulation) requirements. This means it has undergone evaluation to demonstrate substantial equivalence to a legally marketed predicate device, ensuring it meets established safety and performance standards for dental composites in the U.S. and EU markets.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
VOCO GmbH

Sources (51)

  • FDA 510(k) K062343 24 fields · synced Oct 6, 2026
  • FDA UDI e769e648-0015-400d-b588-8fc0876c9a3a 37 fields · synced May 27, 2026
  • FDA UDI 6d97601c-424f-4d1c-880e-539c5951fbc4 37 fields · synced May 29, 2026
  • FDA UDI aa375664-0070-4795-b439-1b63fb534b1c 37 fields · synced May 29, 2026
  • FDA UDI d52c245f-a01d-456c-bd4c-31898aa4be61 37 fields · synced May 29, 2026
  • FDA UDI 6079c9e5-a7bd-40da-9630-e4ebaa8bc69a 37 fields · synced May 29, 2026
  • FDA UDI 683744d4-0c02-4067-9fa8-987922e336c5 37 fields · synced May 29, 2026
  • FDA UDI 794513f6-229b-459d-b1dc-0fc2405f362d 37 fields · synced May 29, 2026
  • FDA UDI 1b08a945-1040-42aa-8c9f-709673ef0d5b 36 fields · synced May 30, 2026
  • FDA UDI 60157d2c-fdfb-41c7-80ff-a80cf0e5cf1a 37 fields · synced May 30, 2026
  • FDA UDI c789fd38-0f15-4b28-b37d-b5b5df84e914 36 fields · synced May 30, 2026
  • FDA UDI 222d06ea-dff9-45cb-9693-4c1445ec8cdf 36 fields · synced May 30, 2026
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  • FDA UDI 4be370cb-a276-4841-939f-aa8f050bfc62 36 fields · synced May 30, 2026
  • FDA UDI 21fc3e3d-c737-4464-9a6e-ccd70a2b3169 37 fields · synced May 30, 2026
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  • FDA UDI c72c65fe-cb4a-4d10-8fcc-ab7417aa682d 37 fields · synced May 30, 2026
  • FDA UDI 913237c6-d8f9-40ad-acf7-76af26934bab 37 fields · synced May 30, 2026
  • FDA UDI 8da91d9d-8ec1-4f51-b887-c50615dd2845 37 fields · synced May 30, 2026
  • FDA UDI 161a72c3-b75c-44ad-a3e9-9916ca3bcbeb 36 fields · synced May 30, 2026
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  • FDA UDI b0aa265e-533a-4f83-bce1-24ef5cdf1c05 37 fields · synced May 30, 2026
  • FDA UDI 97472040-012a-41c7-9473-e8d942374a02 37 fields · synced May 30, 2026
  • EUDAMED 8ede8c74-167d-498d-b6be-1f908e06d068 61 fields · synced Jun 20, 2026
  • EUDAMED a0604aa8-2012-4e0c-afde-8e22305b3095 61 fields · synced Jul 9, 2026
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  • EUDAMED c509c521-90d7-4367-a2a0-23d82bfd5ece 61 fields · synced Jul 10, 2026
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  • EUDAMED e448af8e-ef7f-4612-a17a-4d4945f61055 61 fields · synced Jul 15, 2026
  • EUDAMED 2d881c60-2248-4844-9d1d-12cf353b5a17 61 fields · synced Jul 15, 2026
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  • EUDAMED 844d3369-1a8e-4a3e-98b6-868f6e3696a9 61 fields · synced Jul 16, 2026
  • EUDAMED 358b67b8-9313-44d6-bb44-b3e24a4cf97f 61 fields · synced Jul 16, 2026
  • EUDAMED d8da79b2-dd9d-499a-9c5e-5de54cb926c1 61 fields · synced Jul 17, 2026
  • EUDAMED 26e3ce56-e45c-438a-8b68-23f40788b211 61 fields · synced Jul 19, 2026
  • EUDAMED 0b130c97-565e-49d8-8708-17de3981b5f2 61 fields · synced Jul 19, 2026
  • EUDAMED 2a6c0e72-780b-4b2f-acd2-a5297f6688ee 61 fields · synced Jul 23, 2026
  • EUDAMED b3c33fee-153a-4283-b2c6-33d3a205acbb 61 fields · synced Jul 25, 2026
  • EUDAMED 6a2c8310-e18e-49c9-9b05-7d0ac25c63c9 61 fields · synced Jul 25, 2026