Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

K250267 · Kettenbach GmbH & Co. KG · EBF · Mar 14, 2025 · Dental

Device Facts

• Record ID: K250267
• Device Name: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)
• Applicant: Kettenbach GmbH & Co. KG
• Product Code: EBF · Dental
• Decision Date: Mar 14, 2025
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth. Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.

Device Story

Visalys® Bulk Fill and Visalys® Bulk Flow are light-cured, nano-hybrid restorative composites; used by dentists in clinical settings for tooth structure repair. Visalys® Bulk Fill is modelable; Visalys® Bulk Flow is flowable. Both are applied in layers up to 4 mm thick; cured via light activation. Input: composite material applied to prepared tooth cavities. Output: hardened, tooth-colored restorative material. Benefits: restores tooth function and aesthetics; provides radiopacity for post-operative monitoring. Used for posterior and anterior restorations, core buildups, and splinting. Healthcare providers use these materials to fill cavities and reconstruct tooth anatomy, directly impacting clinical outcomes by restoring structural integrity and preventing further decay.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on bench testing performed in accordance with ISO 4049 (polymer-based restorative materials) and ISO 10993 (biocompatibility). Bench tests included depth of cure, flexural strength, elastic modulus, water sorption, solubility, color stability, radiopacity, volume shrinkage, and shear bond strength. Biocompatibility testing included cytotoxicity, sensitization, and genotoxicity assessments.

Technological Characteristics

Light-cured, methacrylate-based nano-hybrid composites. Visalys® Bulk Fill: ~61 vol.% inorganic fillers (0.01–5 μm). Visalys® Bulk Flow: ~47 vol.% inorganic fillers (0.01–5 μm). Both contain ytterbium fluoride. Radiopacity: 2.5 mm Al (Bulk Fill) and 2.0 mm Al (Bulk Flow). Complies with ISO 4049, ISO 10993, ISO 29022, and ISO 17304. Supplied in syringes or caps for single-use application.

Indications for Use

Indicated for patients with loss of tooth substance due to caries, fractures, dental wear, or developmental disorders. Applicable for Class I, II, III (non-tunneled), and V restorations, deciduous teeth, core buildups, cavity floor elevation/lining, blocking out undercuts, fissure sealing, and tooth splinting.

Regulatory Classification

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.

Predicate Devices

• Venus Bulk Flow ONE (K220605)

Submission Summary (Full Text)

{0}------------------------------------------------

March 14, 2025

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below that.

Kettenbach GmbH & Co. KG Marleen Steger Regulatory Affairs Manager Im Heerfeld 7 Eschenburg, 35713 Germany

# Re: K250267

Trade/Device Name: Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068) Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 13, 2025 Received: March 13, 2025

Dear Marleen Steger:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{1}------------------------------------------------

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory

{2}------------------------------------------------

assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

# Indications for Use

510(k) Number (if known) K250267

# Device Name

Visalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® Bulk Fill 15 x 0.25 g Caps (15062); Visalys® Bulk Flow 1 x 2 g Syringe (15064); Visalys® Bulk Flow 15 x 0.25 g Caps (15066); Visalys® Bulk Flow Intro pack (15067); Visalys® Bulk Intro pack (15068)

# Indications for Use (Describe)

Visalys® Bulk Fill: Loss of tooth substance due to caries, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in deciduous teeth, core buildups, cavity floor elevation, repair of direct restorations after appropriate pretreatment and splinting / locking of teeth.

Visalys® Bulk Flow: Loss of tooth substance due to caries, fractures, dental wear or developmental disorders. Techniques: Class I and II restorations, non-tunneled class III restorations, filling in decidious teeth, core build-ups, cavity lining, cavity floor elevation, blocking out undercuts, repair of direct restorations after appropriate pretreatment, extended fissure sealing and splinting / locking of teeth.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------|
|-------------------------------------------------|

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

# CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

# *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in a bold, blue font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter blue font.

# K250267 - 510(k) Summary

### l. Submitter:

Kettenbach GmbH & Co KG Im Heerfeld 7 35713 Eschenburg Germany

Phone: [phone] Fax: [phone]

# Contact person:

Steger, Marleen Regulatory Affairs Manager Im Heerfeld 7 35713 Eschenburg Germany Phone: + 49 277 4705 0 E-mail: [e-mail]

# Date of preparation:

March 14th, 2025

| II.<br>Device | |
|-----------------------|------------------------------------------------|
| Name of Device: | Visalys® Bulk Fill |
| Common or Usual Name: | Visalys® Bulk Fill |
| Classification Name: | Material, Tooth Shade, Resin (21 CFR 872.3690) |
| Regulatory Class: | II |
| Product Code: | EBF |
| Name of Device: | Visalys® Bulk Flow |
| Common or Usual Name: | Visalys® Bulk Flow |
| Classification Name: | Material, Tooth Shade, Resin (21 CFR 872.3690) |
| Regulatory Class: | II |
| Product Code: | EBF |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image features the logo for KETTENBACH DENTAL. The logo consists of a geometric design of six circles arranged in a triangular pattern above the company name. The text "KETTENBACH" is in a bold, sans-serif font, with "DENTAL" in a lighter, smaller font next to it. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

### = Predicate devices:

Venus Bulk Flow ONE (Kulzer, LLC), K220605 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

### IV. Device Description:

Visalys® Bulk Fill is a light-cured, nano-hybrid filling composite that can be modeled and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in screw syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 82% inorganic fillers by weight. The radiopacity is 2.5 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Fill is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V.

Visalys® Bulk Flow is a light-cured, flowable nano-hybrid filling composite and is available in a universal shade. For adhesive cementation, a dentin-enamel bond is used. The material is available in syringes and can be applied in layers up to 4 mm thick. The filling material contains approx. 72% inorganic fillers by weight. The radiopacity is 2.0 mm aluminium*. The color stability meets the requirements of DIN EN ISO 4049. Visalys® Bulk Flow is thus suitable for both posterior teeth and also for fillings without tunnel preparation in the anterior tooth area, particularly class III and V. Capping is not necessary.

*Aluminium has the same radiopacity as dentin. 1 mm enamel corresponds to 2 mm aluminium.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue graphic of seven circles arranged in a triangular shape above the company name. Below the company name is the tagline "Simply intelligent" in a smaller font size.

### > Indications for Use:

Visalys® Bulk Fill

Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.

Techniques:

- Class I and II restorations .
- Non-tunneled class III restorations ●
- Class V restorations ●
- Fillings in deciduous teeth
- Core build-ups
- Cavity floor elevation ●
- Repair of direct and indirect restorations after appropriate pretreatment ●
- Splinting / locking of teeth ●

# Visalys® Bulk Flow

Loss of tooth substance due to caries, fractures, dental wear or developmental disorders.

Techniques:

- . Class I and II restorations
- Non-tunneled class III restorations ●
- Class V restorations ●
- Fillings in deciduous teeth ●
- Core build-ups ●
- Cavity lining ●
- Cavity floor elevation ●
- Blocking out undercuts
- Repair of direct and indirect restorations after appropriate pretreatment ●
- Extended fissure sealing ●
- Splinting / locking of teeth ●

{7}------------------------------------------------

| imply intelligent<br>1<br>=<br>e |
|----------------------------------|
|----------------------------------|

# able 1: COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE VI.

| | Predicate Devices | Substantial Equivalent Device | | Conclusion |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Venus Bulk Flow ONE | Visalys® Bulk Fill | Visalys® Bulk Flow | |
| Product | | | | |
| Manufacturer | Kulzer, LLC | Kettenbach GmbH & Co. KG | | |
| Product<br>Description | Venus Bulk Flow ONE is a<br>flowable, light-curing, radio-<br>opaque nano-hybrid<br>composite. | Visalys® Bulk Fill is a<br>light-cured, nano-hybrid<br>filling composite that can<br>be modeled and is<br>available in a universal<br>shade. | Visalys® Bulk Flow is a<br>light-cured, flowable<br>nano-hybrid filling<br>composite and is<br>available in a universal<br>shade. | Visalys® Bulk Fill and<br>Visalys® Bulk Flow are<br>similar to Venus Bulk Flow<br>One. All are light-cured<br>nano-hybrid composites. |
| Intended purpose | Flowable light curing nano<br>hybrid composite, radio-<br>opaque | Universal nano-hybrid<br>restorative composite,<br>modelable | Universal nano-hybrid<br>restorative composite,<br>flowable | Visalys® Bulk Fill and<br>Visalys® Bulk Flow are<br>similar to Venus Bulk Flow<br>One. These are light-cured,<br>nano-hybrid composites.<br>Visalys® Bulk Fill is<br>modelable, Visalys® Bulk<br>Flow and Venus Bulk Flow<br>ONE are flowable. The<br>differences in viscosity<br>have no effect on the<br>intended purpose. Visalys®<br>Bulk Fill and Visalys® Bulk<br>Flow are radio-opaque like<br>Venus Bulk Flow ONE,<br>which is not described in<br>the intended purpose. |
| Indications /<br>Techniques | - Class -I, -II, -III and -V<br>direct restorations<br>- First-layer lining for class I<br>and II cavities<br>- Repair of direct and<br>indirect restorations in<br>combination with a suitable<br>adhesive<br>- Splinting loosened teeth<br>resulting from trauma or<br>periodontal associated<br>events | - Class I and II<br>restorations<br>- Non-tunneled class III<br>restorations<br>- Class V restorations<br>- Fillings in deciduous<br>teeth<br>- Core build-ups<br>- Cavity floor elevation<br>- Repair of direct and<br>indirect restorations after<br>appropriate pretreatment | - Class I and II<br>restorations<br>- Non-tunneled class III<br>restorations<br>- Class V restorations<br>- Fillings in deciduous<br>teeth<br>- Core build-ups<br>- Cavity lining<br>- Cavity floor elevation<br>- Blocking out undercuts | All Venus Bulk Flow ONE<br>indications are covered by<br>Visalys® Bulk Fill and<br>Visalys® Bulk Flow.<br>Visalys® Bulk Fill and<br>Visalys® Bulk Flow can<br>also be used for fillings in<br>deciduous teeth, core<br>build-ups, cavity floor<br>elevation and blocking out<br>undercuts (just Visalys®<br>Bulk Flow). |
| 510k Summary | | Rev.2 | | Page 4 von 8 |

510k Summary Issued: 2025-03-14

{8}------------------------------------------------

Image /page/8/Picture/4 description: The image contains the logo for Kettenbach Dental. The logo consists of a blue triangle made of circles, with the text "KETTENBACH DENTAL" written vertically next to it. Below the company name, the words "Simply intelligent" are written in a smaller font. The image also contains the words "STEPH Production Station of Controller Station of Controller Station of Controllers of Controllers of Controllers of Controlle".

| Product | Manufacturer | Predicate Devices<br>Venus Bulk Flow ONE<br>Kulzer, LLC<br>- Extended fissure sealing | Substantial Equivalent Device<br>Visalys® Bulk Fill<br>Kettenbach GmbH & Co. KG<br>- Splinting / locking of teeth | Visalys® Bulk Flow | Conclusion | |
|---------|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| | Basic formulation | Venus Bulk Flow ONE is a<br>light-curing methacrylate-<br>based formulation with the<br>following ingredients:<br>Barium aluminium boro-<br>fluoro-silicate glass,<br>E4BADMA, UDMA,<br>ytterbium fluoride, silicium<br>dioxide, titanium dioxide,<br>BHT, aminobenzoic acid<br>ester, camphorquinone,<br>fluorescent pigments, metal<br>oxide pigments, organic<br>pigments. Venus Bulk Flow<br>ONE contains approx. 41 %<br>filler by vol., the particle size<br>of which is 20 nm – 5 µm. | Main components of<br>Visalys® Bulk Fill are<br>approx. 61 vol. %<br>inorganic fillers in the size<br>range 0.01 – 5 μm<br>including ytterbium<br>fluoride. The polymer<br>base consists of aliphatic<br>dimethacrylates. | - Repair of direct and<br>indirect restorations after<br>appropriate pretreatment<br>- Extended fissure sealing<br>- Splinting / locking of<br>teeth<br>Main components of<br>Visalys® Bulk Flow are<br>approx. 47 vol. %<br>inorganic fillers in the size<br>range 0.01 – 5 μm<br>including ytterbium<br>fluoride. The polymer<br>base consists of aliphatic<br>dimethacrylates. | The basic formulation is<br>similar. The products are<br>methacrylate based and<br>contain inorganic fillers<br>including ytterbium<br>fluoride. The particle sizes are the<br>same. | |
| | Available shades | Universal shade | Universal shade | Universal shade | The products are available<br>in a one-shade system for<br>all tooth shades. | |
| | Single use | Single use only | Single use only | Single use only | The products are single<br>use devices. | |
| | Application system | Syringe (2 g) | Syringe (4 g)<br>Cap (0.25 g) | Syringe (2 g)<br>Cap (0.25 g) | All products are available in<br>a syringe. Visalys® Bulk Fill<br>and Visalys® Bulk Flow are<br>also offered in a cap. | |
| | Performance<br>testing | A comparison of the parameters in respect to mechanical properties was performed. The results demonstrate the<br>substantial equivalence to the predicate device. | | | | |
| | Summary of<br>Product | The indication of the subject devices is the same for the predicate device. Contraindications, application, and side<br>effects for both products are basically the same – there is a slight difference in the wording. | | | | |

510k Summary Issued: 2025-03-14

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo consists of a blue triangle made up of six circles on the left, with the text "KETTENBACH DENTAL" to the right of the triangle. Below the company name is the slogan "Simply intelligent".

| | Predicate Devices | Substantial Equivalent Device | | Conclusion |
|----------------------------------------------------------------------------------------|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--------------------|
| Product | Venus Bulk Flow ONE | Visalys® Bulk Fill | | Visalys® Bulk Flow |
| Manufacturer | Kulzer, LLC | Kettenbach GmbH & Co. KG | | |
| Description,<br>Intended purpose<br>Indications,<br>Contraindications /<br>Precautions | | | | |
| Summary<br>Chemical<br>Composition | | The Visalys® Bulk Flow formulation has been thoroughly assessed for biocompatibility. The results for Visalys® Bulk<br>Flow covers Visalys® Bulk Fill since the most relevant ingredients from a toxicological standpoint are present in a<br>higher concentration in Visalys® Bulk Flow. | | |
| Summary of<br>Finished<br>Device<br>Specification | | The results demonstrate the substantial equivalence to the predicate device. | | |

{10}------------------------------------------------

- ●
- Toxicological risk assessment
- Chemical characterization ●
- Evaluation of biocompatibility

The tests showed that the biocompatibility data of Visalys® Bulk Flow (and therefore Visalys® Bulk Fill) is comparable to other materials on the market. Hence, no toxicological risks and resulting hazards for patients, users and third parties can be concluded.

# Non-clinical performance:

According to ISO 4049 "Polymer-based restorative materials" bench testing was performed to allow an evaluation of the mechanical properties of Visalvs® Bulk Fill and Visalys® Bulk Flow in comparison to Venus Bulk Flow ONE (K220605).

| Sensitivity to light | Acc. to ISO 4049 / 7.9 |
|---------------------------------------------------------|-------------------------------------------------------------|
| Depth of cure | Acc. to ISO 4049 / 7.10 |
| Flexural strength | Acc. to ISO 4049 / 7.11 |
| Elastic modulus | Acc. to ISO 4049 / 7.11 |
| Water sorption | Acc. to ISO 4049 / 7.12 |
| Solubility | Acc. to ISO 4049 / 7.12 |
| Shade of restorative<br>materials | Acc. to ISO 4049 / 7.13<br>and ISO 7491 / ANSI ADA Spec. 80 |
| Color stability after irradiation<br>and water sorption | Acc. to ISO 4049 / 7.13<br>and ISO 7491 / ANSI ADA Spec. 80 |
| Radio-opacity | Acc. to ISO 4049 / 7.14<br>and ISO 13116 |
| Volume shrinkage | Acc. to ISO 17304 |
| Shear bond strength to dentin | Acc. to ISO 29022 |
| Shear bond strength to<br>restorative materials | Acc. to ISO 29022 |
| Duration of light curing | Internal test method |
| Extrusion force1) | Internal test method |
| Consistency2) | Internal test method |
| High shear viscosity1) | Internal test method |
| Low shear viscosity1) | Internal test methods |
| Universal color | In-vitro test |

## VII. Performance Data:

Biocompatibility:

.

The following performance data were provided in substantial equivalence determination. The biocompatibility evaluation was conducted in accordance with ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process," as recognized by FDA.:

- . Cytotoxicity
- Sensitization
- Genotoxicity
- -
- ISO 10993-10 ISO 10993-3

ISO 10993-5

- ISO 10993-17
- ISO 10993-18
- ISO 7405

Image /page/10/Picture/23 description: The image contains the text "Rev.2". The text is written in a simple, sans-serif font. The letters are black against a white background.

Image /page/10/Picture/24 description: The image shows the logo for Kettenbach Dental. The logo consists of six blue circles arranged in a triangular pattern above the text "KETTENBACH DENTAL" in blue. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

{11}------------------------------------------------

Image /page/11/Picture/0 description: The image shows the logo for KETTENBACH DENTAL. The logo features a graphic of six blue circles arranged in a triangular shape above the company name. The text "KETTENBACH" is in a bold, sans-serif font, and the word "DENTAL" is in a lighter, slightly smaller font. Below the company name is the tagline "Simply intelligent" in a smaller, lighter font.

1) Test just for Visalys® Bulk Flow; 2) Test just for Visalys® Bulk Fill Summary:

Based on the performance data, Visalys® Bulk Fill and Visalys® Bulk Flow were found to have a safety and effectiveness profile that is similar to the predicate device.

Clinical Performance Data:

Data from clinical studies was not provided.

### VIII. Conclusion:

Based on similarities in technology and indications for use, together with results on nonclinical performance testing, Visalys® Bulk Fill and Visalys® Bulk Flow are substantially equivalent to the predicate device Venus Bulk Flow ONE (K220605).