(50 days)
No
The description focuses on the material properties and intended uses of a dental composite, with no mention of AI or ML.
No
The device is a dental composite used for restorations and sealing, which is a structural or cosmetic modification rather than a direct therapeutic treatment for a disease or condition. While it has benefits like preventing decay, its primary function isn't to treat or diagnose a disease.
No
The device is a restorative material (composite) used for filling cavities and repairing teeth, not for diagnosing medical conditions.
No
The device description clearly states it is a "light curing, radio-opaque nano-hybrid composite," which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that Venus Bulk Flow ONE is a dental composite applied directly to the tooth structure within the oral cavity. It is not used to analyze samples taken from the body.
- The device description and intended use focus on restorative dental procedures. The applications listed (fissure sealing, cavity lining, direct restorations, repairs, splinting) are all related to physically restoring or modifying tooth structure.
- There is no mention of analyzing biological samples or providing diagnostic information. The device's function is to fill, seal, or bond, not to detect or measure substances in a biological specimen for diagnostic purposes.
Therefore, Venus Bulk Flow ONE is a dental restorative material, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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
Product codes
EBF
Device Description
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.
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 indirect restorations in combination with a suitable adhesive, splinting loosened teeth resulting from trauma or periodontal associated events.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth structure
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental patients
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Non-clinical bench testing:
The following testing was performed:
- light sensitivity
- depth of cure
- flexural strength
- water sorption
- water solubility
- color stability
- 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.
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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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 sensitivityto | |
| dental OP light | > 60 s |
| 5.2.8 depth of | |
| cure | > 1,5 mm |
| 5.2.9 flexural | |
| strength | > 80 MPa |
| 5.2.10 water | |
| sorption | 100%-Al and |
| SD |