Grandio SO Heavy Flow is a steady but shear thinning, methacrylate based dental filling composite for all cavity classes with increased inorganic filler content and excellent physical properties e.g. wear resistance, compressive strength, color stability in the mouth compared with other flow composites. Grandio SO Heavy Flow comes in different tooth like shades of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting esthetic restorations.

Grandio SO Heavy Flow is processed according to current state of the art procedures for light curing flowable dental composites, thus, Grandio SO Heavy Flow can be applied by any dental professional who is familiar with this kind of materials. Like the predicate device Grandio Flow it can easily be placed and processed prior to curing and finishing.

Grandio SO Heavy Flow will be offered in the following presentations:

, syringes of 2g
-Caps of 0.25g

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Grandio SO Heavy Flow device:

Important Note: The provided document is a 510(k) summary for a dental filling composite. These summaries typically describe the device's equivalence to a predicate rather than detailed studies proving performance against formal acceptance criteria in the way one might see for, say, an AI-powered diagnostic system. As such, many of the requested fields regarding detailed study design, ground truth, and expert involvement are not applicable or not provided in this type of document. I will fill in what is available and indicate when information is not present.

1. Table of Acceptance Criteria and Reported Device Performance

Parameter / Acceptance Criteria Category	Reported Device Performance (Grandio SO Heavy Flow)	Basis for Acceptance (Predicate Device)
Intended Use	- Filling minimally invasive cavities of all classes - Filling small class I cavities and extended fissure sealing - Filling class II - V cavities including V-shaped defects and cervical caries - Blocking out undercuts - Lining or coating cavities - Repairing fillings and veneers - Luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)	Same indications as predicate device Grandio Flow (K051868, K101213)
Technological Characteristics	- Methacrylate based dental filling composite - Nanohybrid technology (optimized mixing ratio of inorganic filler particles in different sizes) - Increased inorganic filler content - Excellent physical properties (e.g., wear resistance, compressive strength, color stability)	Based on nanohybrid technology, similar components to predicate device Grandio Flow
Physical Properties	Optimized with regard to several physical parameters (e.g., wear resistance, compressive strength, color stability)	Improved compared with predicate Grandio Flow (K051868, K101213)
Biocompatibility/Safety	Prior use of all components in legally marketed devices.	Prior use in legally marketed devices (supports decision that additional testing for cytotoxicity, mutagenicity, and biocompatibility studies are not necessary).

Explanation of "Acceptance Criteria" for this device: For a 510(k) submission like this, the "acceptance criteria" are primarily established by demonstrating substantial equivalence to a previously legally marketed predicate device. This means the new device must have the same intended use as the predicate and either the same technological characteristics or, if different, those differences must not raise new questions of safety and effectiveness. The document highlights "improved physical features" which suggests meeting or exceeding predicate performance rather than specific numerical acceptance thresholds.

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided: This 510(k) summary does not describe a "test set" in the context of an algorithm or diagnostic study. The "testing" referred to is related to the physical properties of the dental material itself, likely performed in a lab setting rather than on patient data. There is no mention of "samples" in terms of patient cases or data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: This information is not relevant to a dental material 510(k) submission. There is no concept of "ground truth" established by experts in the context of materials' physical properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: This is not relevant for this type of device and submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable / Not Provided: This document describes a dental filling material, not an AI or diagnostic tool. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable / Not Provided: This document describes a dental filling material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not Applicable / Not Provided: For a dental material, "ground truth" would refer to measured physical and chemical properties (e.g., compressive strength, wear resistance, color stability, biocompatibility). These are typically determined through standardized laboratory tests, not expert consensus or pathology in the diagnostic sense. The document states "performance data and results" and "improved physical features" but does not detail the specific methodology for establishing this "ground truth" beyond stating "optimized."

8. The sample size for the training set

Not Applicable / Not Provided: This document describes a dental filling material, not an AI model.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: This document describes a dental filling material, not an AI model.

Summary of the Study (as described in the 510(k) Summary):

The "study" in this context is a substantial equivalence demonstration based on comparing the Grandio SO Heavy Flow to predicate devices (Grandio Flow, K051868, K101213).

Purpose: To demonstrate that Grandio SO Heavy Flow is as safe and effective as previously legally marketed devices for its intended use.
Methodology:
- Comparison of Intended Use: Grandio SO Heavy Flow has the same intended use as the predicate devices.
- Comparison of Technological Characteristics: Grandio SO Heavy Flow is a nanohybrid composite, similar to the predicate. The components are also similar, allowing the manufacturer to leverage prior biocompatibility testing. The new device has "increased inorganic filler content and excellent physical properties" (e.g., wear resistance, compressive strength, color stability) which are explicitly stated as "improved physical features" compared to the predicate.
- Performance Data: The document explicitly states "For details of product performance data please see section 9 (substantial equivalence comparison)" but this section is not provided in the extracted text. However, it mentions "performance data and results also provide support for the safety and effectiveness."
- Biocompatibility: The prior use of all components in legally marketed devices is deemed sufficient to support the decision that additional cytotoxicity, mutagenicity, and biocompatibility studies with the final formulation are not necessary.

Conclusion from the document: The FDA found Grandio SO Heavy Flow to be substantially equivalent to the predicate devices, allowing it to be marketed. This decision is based on the information provided regarding intended use, technological characteristics, and performance data (though not detailed here) that demonstrate the new device is as safe and effective as its predicates.

Summary

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102354

510(k) SUMMARY

Contact:	M. Th. Plaumann
Date prepared:	August 16, 2010	NOV - 8 20
Trade or proprietary name:	Grandio SO Heavy Flow
Classification name:	Material, Tooth Shade, Resin (872.3690)
Predicate device:	Grandio Flow, K051868, VOCO GmbHGrandio Flow, K101213, VOCO GmbH

Device description:

Intended use:

Grandio SO Heavy Flow is intended for use as:

filling minimally invasive cavities of all classes -
filling small class I cavities and extended fissure sealing -
filling class II - V cavities including V-shaped defects and cervical caries
blocking out undercuts -
lining or coating cavities
repairing fillings and veneers
luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) -

Technological characteristics:

Grandio SO Heavy Flow and the legally marketed device Grandio Flow, K051868 (VOCO GmbH) share the same indications but have improved physical features. Grandio SO Heavy Flow has been optimized with regard to several physical parameters.

Grandio SO Heavy Flow based on nanohybrid technology just like the predicate device Grandio Flow. This technology relies on the optimization of the mixing ratio of inorqanic filler particles in different sizes.

The components of Grandio SO Heavy Flow serve the same purpose as the ingredients of the predicate device Grandio Flow.

The prior use of all of the components of Grandio SO Heavy Flow in legally marketed devices supports our decision that additional testing for cytotoxicity and mutagenicity as well as additional biocompatibility studies with the final formulation are not necessary.

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We believe that the prior use of the components of Grandio SO Heavy Flow in legally marketed devices and the performance data and results also provide support for the safety and effectiveness of Grandio SO Heavy Flow for the intended use.

VOCO GmbH, September 6th, 2010

Dr. Thorsten Gerkensmeier (Regulatory Affairs)

ﺔ، ﻭ

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Device Description and Executive Summary

Grandio SO Heavy Flow is a stready but shear thinning, methacrylate based dental filling composite for all cavity classes with increased inorganic filler content and excellent physical properties e.g. wear resistance, compressive strength, color stability in the mouth compared with other flow composites. Grandio SO Heavy Flow comes in different tooth like shades of optimal opacity and can be easily polished. It is therefore highly qualified for long lasting esthetic restorations.

Grandio SO Heavy Flow will be offered in the following presentations:

, syringes of 2g
-Caps of 0.25g

Grandio SO Heavy Flow is intended for use as:

filling minimally invasive cavities of all classes ।
- filling small class I cavities and extended fissure sealing
filling class II V cavities including V-shaped defects and cervical caries -
blocking out undercuts
lining or coating cavities -
repairing fillings and veneers
luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.)

Grandio SO Heavy Flow is claimed to be substantially equivalent to Grandio Flow. K051868, K101213 (VOCO GmbH)

For details of product performance data please section 9 (substantial equivalence comparison).

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its wings or body. The bird is positioned above a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged around the circumference of the circle, framing the bird symbol.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Manfred T. Plaumann Voco GmbH Anton-Flettner-Strasse 1-3 Cuxhaven Germany D-27472

NOV - 8 2010

Re: K102354

Trade/Device Name: Grandio SO Heavy Flow Regulation Number: 21 CFR 872,3690 Regulatory Class: II Product Code: EBF Dated: October 13, 2010 Received: October 15, 2010

Dear Mr. Plaumann:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and have determined the device is substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendrers or to devices that have been reclassified in accordance with the provisions of the Federal Food, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affer innuncu device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP investions, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under secions 5 1 through 542 of the Act for devices under the Electronic Product Radiation Control neversisens, or other Federal laws or regulations.

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Page 2 – Mr. Manfred T. Plaumann

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. An FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market, but it does not mean that FDA approves your device. Therefore, you may not promote or in any way represent your device or its labeling as being approved by FDA.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (240) 276-6649. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or at (240) 276-3150.

Sincerely yours

Susanner

· Anthony D. Watson, BS, MS, MBA Director Division of Anesthesiology, General Hospital, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use Statement

510(k) Number: K 102354

Grandio SO Heavy Flow _ Device Name:

Indications for Use:

Grandio SO Heavy Flow is intended for use as:

filling minimally invasive cavities of all classes -
filling small class I cavities and extended fissure sealing -
filling class II V cavities including V-shaped defects and cervical caries -
blocking out undercuts -
lining or coating cavities -
repairing fillings and veneers -
luting translucent prosthetic pieces (e.g., full ceramic crowns, etc.) -

Prescription Use _ X

Over-The-Counter Use

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Suza Runner

(Division Sign-Off) (Division Sign-On)
Division of Anesthesiology, General Hospital
Clivision of Anesthesiology, General Boxiness Infection Control, Dental Devices

510(k) Number: K102354

Regulation Number and Section

§ 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.