(50 days)
Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite. The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinical benefit.
The provided text describes the regulatory submission for the Venus Bulk Flow ONE, a dental restorative material. It focuses on demonstrating substantial equivalence to a predicate device (Venus Diamond Flow, K091635) primarily through non-clinical bench testing. There is no information regarding AI/ML device acceptance criteria or performance.
Here's the breakdown of the information requested, based on the provided text:
1. Table of acceptance criteria and the reported device performance:
| Parameter | Required Specification (Acceptance Criteria per ISO 4049:2019) | Reported Device Performance (Venus Bulk Flow ONE) |
|---|---|---|
| Sensitivity to dental OP light | > 60 s | Exceeded specification (results equal or better than predicate) |
| Depth of cure | > 1.5 mm | Achieved 4 mm (predicate device was 2 mm) |
| Flexural strength | > 80 MPa | Exceeded specification (results equal or better than predicate) |
| Water sorption | < 40 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Water solubility | < 7.5 µg/mm³ | Exceeded specification (results equal or better than predicate) |
| Color stability | No more than slight change in color | Exceeded specification (results equal or better than predicate) |
| Radio-opacity | > 100%-Al and SD < 50%, if claimed | Exceeded specification (results equal or better than predicate) |
2. Sample sized used for the test set and the data provenance:
The document describes non-clinical bench testing according to ISO 4049:2019. It does not specify sample sizes for these tests. The data provenance is from internal studies conducted by Kulzer, LLC.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The ground truth for this device is based on objective, quantifiable physical and chemical properties measured through laboratory bench testing according to international standards (ISO 4049:2019), not expert consensus.
4. Adjudication method for the test set:
Not applicable. The "test set" here refers to material samples undergoing laboratory characterization against predefined ISO standards.
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. This is a dental restorative material, not an AI/ML diagnostic or assistive device. There were no human readers or AI assistance involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a dental restorative material, not an AI/ML algorithm.
7. The type of ground truth used:
The ground truth used for demonstrating device performance is based on the specified requirements of international standard ISO 4049:2019 for polymer-based restorative materials. These are objective, measurable physical and chemical properties.
8. The sample size for the training set:
Not applicable. This is a conventional medical device, not an AI/ML device that requires a training set. The "development" of the product involved modification of materials and composition, not training of an algorithm.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this device.
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 21, 2022
Kulzer, LLC Marc Henn Director QA/RA 4315 S. Lafayette Blvd South Bend, Indiana 46614
Re: K220605
Trade/Device Name: Venus Bulk Flow ONE Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: February 22, 2022 Received: March 2, 2022
Dear Marc Henn:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael E. Adjodha, M.ChE. 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
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Indications for Use
510(k) Number (if known) K220605
Device Name Venus Bulk Flow ONE
Indications for Use (Describe) Extended fissure sealing First-layer lining for class I and class II cavities Class I, II, III and V direct restorations Repair of direct and indirect restorations in combination with a suitable adhesive Splinting loosened teeth resulting from trauma or periodontal associated events
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image contains the logo for Kulzer Mitsui Chemicals Group. On the left is a green circle with a white tooth in the center. To the right of the circle is the word "KULZER" in gray, with the words "MITSUI CHEMICALS GROUP" in a smaller font below it.
SUBJECT: Venus Bulk Flow ONE Special 510(k) Summary- K220605
Date: February 15, 2022
Owner: Kulzer, LLC 4315 S. Lafayette Blvd. South Bend, IN 46614
PRIMARY CORRESPONDENT: Marc Henn, Director of QA/RA Phone (574) 261-2555 Email Marc.Henn(@kulzer-dental.com
ADDITIONAL CORRESPONDENT: David Vincent, Director of QA/RA Phone (574) 298-5424 Email David.Vincent(@kulzer-dental.com
Trade Name (80792): Venus Bulk Flow ONE Common Name: Restorative Material Product Code: 76 E BF Classification Name (21 CFR 872.3690): Material, Tooth Shade Resin 807.92(a)3 Legally marketed device of which equivalence is claimed: VenusDiamond Flow (K091635)
[807.92(a)(4)] Description of Device:
Venus Bulk Flow ONE is a light curing, radio-opaque nano-hybrid composite.
The uncured dental composite is introduced into the oral cavity to be applied and cured to the tooth structure or restoration pre-treated by the dentist, thus achieving the clinicalbenefit.
Venus Bulk Flow ONE is used for extended fissure sealing, first-layer lining for class I and class II cavities, Class I, II, III and V direct restorations, repair of direct and indirectrestorations in combination with a suitable adhesive, splinting loosened teeth resulting from trauma or periodontal associated events.
Product Image:
Image /page/3/Picture/14 description: The image shows a collection of dental products. The products are packaged in white boxes with the brand name "Venus" prominently displayed. There are also syringes and other dental tools visible in the image, suggesting a comprehensive dental care kit.
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Image /page/4/Picture/0 description: The image shows the logo for Kulzer, a Mitsui Chemicals Group company. The logo consists of a green circle with a white tooth inside, followed by a vertical gray line. To the right of the line is the word "KULZER" in large, gray, sans-serif font, with the words "MITSUI CHEMICALS GROUP" in smaller font underneath.
| Parameter | Required Specification |
|---|---|
| 5.2.7 sensitivitytodental OP light | > 60 s |
| 5.2.8 depth ofcure | > 1,5 mm |
| 5.2.9 flexuralstrength | > 80 MPa |
| 5.2.10 watersorption | < 40 µg/mm3 |
| 5.2.10 watersolubility | < 7,5 µg/mm3 |
| 5.4. colourstability | no more thanslight change incolor |
| 5.5 radio-opacity | > 100%-Al andSD < 50%, ifclaimed |
[807.92(a)(5)| Intended Use:
Venus Bulk Flow ONE is used for extended fissure sealing, first-layer lining for class I and class II cavities, Class I, II, III and V direct restorations, repair of direct and indirectrestorations in combination with a suitable adhesive, splinting loosened teeth resulting from trauma or periodontal associated events.
The predicate device (K091635) is restricted to areas not subjected to masticatory forces. This is the primary difference between the subject device Venus Bulk Flow ONE and the predicate device which is Venus Diamond Flow (K091635). The intended population for use is dental patients needing restorations. The expanded indication of not being limited to areas that are notsubjected to masticatory surfaces allows for more broad use of this product in dental restorations for said indications. Internal studies per ISO 4049 yielded results that demonstrate this product is appropriate for use in those areas safely.
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Image /page/5/Picture/0 description: The image contains the logo for Kulzer, a company that is part of the Mitsui Chemicals Group. The logo features a green circle with a white tooth shape inside, followed by the word "KULZER" in bold, gray letters. Below "KULZER" is the text "MITSUI CHEMICALS GROUP" in a smaller font, also in gray. The logo is clean and modern, with a focus on dental health and chemical innovation.
[807.92(a)(6)] Technological Characteristics:
The basic fundamental scientific technology of the subject device Venus Bulk Flow ONE versusthe predicate device Venus Diamond Flow (K091635) are identical. The chemistries are identical. Conditions of use, time of patient contact, physical properties, biocompatibility, tissue contact, patient population, users are all identical.
The differences are different composite amount in the packaging, depth of cure, and less restrictive indications for use. The subject device Venus Bulk Flow ONE syringe contains 2g of material while the predicate device Venus Diamond Flow (K091635) contains 1.8g. This has no effect on safety or efficacy. The depth of cure for the subject device Venus Bulk Flow ONE is 4mm while for the predicate device Venus Diamond Flow (K091635) it is 2mm. The 4mm curing depth is achieved by modification of the opacity (color) only. This has no effect on safety or efficacy. The remaining difference which is a less restrictive indications for use due to the restriction not to use on masticatory surfaces also has no effect on safety and efficacy. The predicate device Venus Diamond Flow (K091635) same as subject device Venus Bulk Flow ONE was tested perISO 4049 and met the requirements therein. Since both devices meet the ISO 4049 requirements, both could have had this restriction removed. At the time Venus DiamondFlow (K091635) was cleared and released for sale, it simply was not thought of.
[807.92(b)(1)]: Non-clinical bench testing:
The following testing was performed:
- light sensitivity O
- 0 depth of cure
- 0 flexural strength
- 0 water sorption
- 0 water solubility
- 0 color stability
- o radio-opacity
In all cases, results were either equal or better than the predicate Venus Diamond Flow(K091635) and exceeded specifications as required by ISO 4049:2019. With these results in mind, the subject device Venus Bulk Flow ONE is better than or equivalent tothe predicate device Venus Diamond Flow (K091635) in all cases.
[807.92(b)(2)] Clinical Performance Data:
A formal clinical trial was not performed.
Venus Bulk Flow ONE is the latest product development of Kulzer's dental flowable composites. It is based on a modification of Venus Diamond Flow, marketed since 2009. According to the performed Equivalence Evaluation, the devices Venus Bulk FlowONE and Venus Diamond Flow can be considered equal. Venus Bulk Flow ONE was developed to further simplify and accelerate the process of direct composite restorationswith good aesthetics.
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Image /page/6/Picture/0 description: The image shows the logo for Kulzer, a company that is part of the Mitsui Chemicals Group. The logo consists of a green circle with a white tooth inside, followed by the word "KULZER" in gray, with the words "MITSUI CHEMICALS GROUP" underneath in a smaller font. The logo is simple and modern, and the use of green suggests a focus on health or nature.
The translucency of Venus Bulk Flow ONE is reduced to the possible minimum, while still allowing 4 mm of curing depth. In this way, the bulk-fill technique is possible without compromise in aesthetics. Both Venus Diamond Flow and Venus Bulk Flow ONE meet the performance requirements of ISO 4049:2019. There is no clinically significant difference in the safety and clinical performance of the devices Venus Diamond Flow and Venus Bulk Flow ONE. Therefore, the current clinical evaluation "Dental Composites" remains valid and applies to Venus Bulk Flow ONE. This statement verifies that Venus Bulk Flow ONE, when used under the conditions andfor the purposes intended, will perform only with known and foreseeable risks and side effects (inclusively from foreseeable misuse). No new risks or other previously unknownsafety issues or side effects were identified.
807.92(b)(3) Conclusions from Non-clinical and Clinical Tests:
Based on the above non-clinical and clinical evaluation data/tests, the subject device Venus Bulk Flow ONE is as safe and effective as the predicate device Venus DiamondFlow(K091635).
807.92(d) Information reasonably deemed necessary by FDA:
Any additional information reasonably deemed necessary by the FDA will be provided ina timely a fashion as possible.
807.92(e) Indications for Use:
| Subject Device VenusBulk Flow ONE(K220605) | Predicate Device VenusDiamond Flow (K091635) | |
|---|---|---|
| IndicationforUse | • Extended fissure sealing• First-layer lining for classI and II cavities• Class-I, -II, -III and -Vdirect restorations• Repair of direct andindirect restorations incombination with a suitableadhesiveSplinting loosened teethresulting from trauma orperiodontal associatedevents | • Enlarged fissure sealing•Cavity lining – as the firstlayer for Class I and IIcavities•Class V fillings•Minimally invasive Class Iand II fillings in areas notsubjected to masticatoryforces•Minimally invasive Class IIIfillings• Small repairs of direct andindirect restorationscombined with a suitablebonding agentInterlocking of loosened teeth |
§ 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.