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K Number
K251239
Device Name
GrandioSO Unlimited
Manufacturer
VOCO GmbH
Date Cleared
2025-05-21

(29 days)

Product Code
EBF
Regulation Number
872.3690
Type
Special
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • class I to V restorations
  • reconstruction of traumatically damaged anteriors
  • facetting of discolored anteriors
  • correction of shape and shade for improved aesthetic appearance
  • locking, splinting of loose teeth
  • repairing veneers
  • restoration of deciduous teeth
  • core-build-up under crowns
  • composite inlays
Device Description

Not Found

AI/ML Overview

The provided FDA 510(k) Clearance Letter for "GrandioSO Unlimited" indicates that the device has been cleared as a "Tooth Shade Resin Material" (Product Code: EBF). This means it is a dental filling material, and the information provided in the document pertains to its substantial equivalence to predicate devices, its intended uses, and regulatory compliance.

Crucially, this document is a regulatory clearance for a physical dental material, not an AI/Software as a Medical Device (SaMD). Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" as they relate to AI/SaMD performance (e.g., accuracy, sensitivity, specificity for diagnostic or assistive AI) are not applicable to this specific dental material clearance letter.

The clearance for a dental material like GrandioSO Unlimited is based on demonstrating substantial equivalence to a legally marketed predicate device, typically through:

  • Material properties testing: Demonstrating that the physical, chemical, and mechanical properties (e.g., flexural strength, wear resistance, color stability, biocompatibility) are comparable to the predicate device.
  • Biocompatibility testing: Ensuring the material is safe for use in the body.
  • Clinical use claims: Showing that the material can be used for the stated indications (e.g., Class I to V restorations) effectively and safely, often supported by existing literature or non-clinical data if the material formulation is similar to established products.

Therefore, I cannot extract the requested information (1-9) from the provided text because these elements are specific to the validation of AI/SaMD performance, not the regulatory clearance of a dental restorative material.

The document states:

  • Device Name: GrandioSO Unlimited
  • Regulation Name: Tooth Shade Resin Material
  • Product Code: EBF
  • Indications for Use: Class I to V restorations, reconstruction of traumatically damaged anteriors, facetting of discolored anteriors, correction of shape and shade for improved aesthetic appearance, locking, splinting of loose teeth, repairing veneers, restoration of deciduous teeth, core-build-up under crowns, composite inlays.

These are typical uses for a dental composite material. The "study" proving it meets "acceptance criteria" would be a battery of standard dental material tests and biocompatibility assessments, demonstrating its equivalence to existing, legally marketed tooth shade resin materials. This letter does not contain the specifics of those material tests or any AI/SaMD-related performance metrics.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.