GrandioSO x-tra
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
by VOCO GmbH
Identity
- Trade Name
- GrandioSO x-tra EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- GrandioSO x-tra EUDAMEDGrandioSO x-tra Caps 16x0.25g A2 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDIGrandioSO x-tra Caps 16x0.25g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDIGrandioSO x-tra Caps 16x0.25g A3 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDI
- Model / Reference
- 2716 EUDAMEDFDA UDI2715 EUDAMEDFDA UDI2717 EUDAMEDFDA UDI2718 EUDAMED
- Description
- GrandioSO x-tra Caps 16x0.25g A2 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDIGrandioSO x-tra Caps 16x0.25g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDIGrandioSO x-tra Caps 16x0.25g A3 GrandiSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterized by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDI
Identifiers
- Catalog Number
- 2716 FDA UDI2715 FDA UDI2717 FDA UDI
- Primary DI / UDI-DI
- E22127161 EUDAMEDFDA UDIE22127151 EUDAMEDFDA UDIE22127171 EUDAMEDFDA UDIE22127181 EUDAMED
- Basic UDI-DI
- ++E2210158000000000F9 EUDAMED
- 510(k) Number
- K181312 FDA 510(k)
- 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 EUDAMEDClass 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
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
GrandioSO x-tra is a nano-hybrid bulk restorative composite material designed for dental restorations. It combines high filler content (86% by weight) with low polymerization shrinkage (1.4% by volume), providing durable and aesthetically pleasing results for posterior restorations.
This material is supplied in shades A1, A2, A3, and universal, ensuring versatility for various clinical applications. It is intended for single-use, non-sterile use in dental settings and has achieved FDA 510K clearance under the Dental advisory committee. The product is regulated under the MDR framework and is classified under product code EBF.
Frequently asked questions
What types of dental restorations is the GrandioSO x-tra composite material designed for, and why is it suitable for those applications?
The GrandioSO x-tra is specifically formulated for posterior dental restorations, such as molars and premolars. It is designed for these applications due to its high filler content (86% by weight), which enhances durability and strength, and its low polymerization shrinkage (1.4% by volume), reducing the risk of gaps or sensitivity over time. This combination ensures long-lasting, aesthetically pleasing results in areas requiring robust material performance.
Is the GrandioSO x-tra composite material single-use or reusable, and what does this mean for clinical workflow?
The GrandioSO x-tra is intended for single-use only. This means each capsule or container is designed for one application, ensuring sterility and consistency in clinical settings. Clinicians should not reuse the material, as this could compromise its performance or introduce contamination risks, aligning with standard dental practice for composite restoratives.
What shade options are available for the GrandioSO x-tra, and how do these cater to clinical needs?
The GrandioSO x-tra is supplied in four shades: A1, A2, A3, and a universal shade. These options provide versatility for matching natural tooth coloration across different patients and clinical scenarios, particularly in posterior restorations where shade matching is critical for aesthetic integration with surrounding teeth.
How is the GrandioSO x-tra composite material regulated, and what does this mean for its use in dental practices?
The GrandioSO x-tra holds FDA 510K clearance under the Dental advisory committee, indicating it is deemed substantially equivalent to a legally marketed predicate device. It is also regulated under the Medical Device Regulation (MDR) framework in Europe. This means it meets regulatory standards for safety and effectiveness, allowing dental professionals to use it with confidence in practices adhering to FDA or MDR compliance.
Is the GrandioSO x-tra sterile, and what are the implications for its handling in a dental office?
The GrandioSO x-tra is supplied in a non-sterile form, which is typical for dental composites intended for single-use in controlled environments like dental offices. While not pre-sterilized, its single-use nature minimizes contamination risks if handled according to standard dental aseptic protocols. Clinicians should follow proper infection control measures, such as using sterile instruments and maintaining a clean workspace, to ensure safe application.
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. Sources consulted: GrandioSO x-tra - Composites | VOCO GmbH, GrandioSO x-tra - Nano-Hybrid Composite | VOCO GmbH, GrandioSO x-tra: Bulk Fill Nanohybrid Composite - VOCO
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K181312 | Class II | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
Sources (8)
- FDA 510(k) K181312 24 fields · synced Oct 6, 2026
- FDA UDI 2822c2cd-5df4-4363-bf7c-cd2375783899 35 fields · synced May 30, 2026
- FDA UDI 42f5aef2-034d-44b6-afae-dd3535e83106 35 fields · synced May 30, 2026
- FDA UDI c70c3195-525d-4e70-8ef1-81cb132cd506 35 fields · synced May 30, 2026
- EUDAMED 10509c4e-e6d1-41bd-bf14-4d8298efbaf4 61 fields · synced Jul 9, 2026
- EUDAMED 97b96512-0407-4eeb-a89d-4c5d3276710c 61 fields · synced Jul 11, 2026
- EUDAMED a528c21c-0071-400f-97d0-917e6ffd73c8 61 fields · synced Jul 20, 2026
- EUDAMED 40462bd5-3013-4dcd-b7b3-c22d742cfda4 61 fields · synced Jul 26, 2026