(119 days)
Not Found
No
The document describes a dental composite material with antibacterial properties due to the addition of QASi particles. There is no mention of any software, algorithms, or data processing that would indicate the use of AI or ML. The performance study described is a clinical trial evaluating the material's effect on demineralization, not the performance of an AI/ML algorithm.
No
The device, a dental composite, is used for restorative purposes, such as filling cavities and repairing teeth. While it has an antibacterial component to reduce demineralization, its primary function is not to treat a disease or medical condition but rather to restore the form and function of teeth, classifying it as a restorative material rather than a therapeutic device.
No
The device description clearly states that the Infinix™ Family of Dental Composites are light-cured, resin-based composite materials used for restorations and other dental procedures. These are restorative materials, not diagnostic tools.
No
The device is a physical dental composite material, not software. The description details its chemical composition and physical properties, and the performance studies involve clinical testing of the material itself.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended uses listed are all related to the direct restoration and repair of teeth within the oral cavity. This is a therapeutic and restorative function, not a diagnostic one performed on samples outside the body.
- Device Description: The device is a dental composite material designed to be placed directly into a patient's mouth and cured. While it has an antibacterial mechanism, this mechanism acts in situ within the mouth, not on a sample in a laboratory setting.
- No Mention of In Vitro Testing: The description of the performance study is an in-situ clinical study, meaning it was conducted within the living environment (the patient's mouth via a denture model). There is no mention of testing patient samples (like blood, urine, tissue, etc.) outside the body for diagnostic purposes.
- Anatomical Site: The anatomical site is the tooth cavity, which is within the patient's body. IVDs typically analyze samples taken from the body.
In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological state, state of health, or disease or congenital abnormality. This device does not fit that definition.
N/A
Intended Use / Indications for Use
Infinix™ Universal Composite
- · Restorations in the posterior region (Class I and II)
- · Anterior restorations (Class III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Veneering of discolored anterior teeth
- · Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- · Repair of composite/ceramic veneers
The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Flowable Composite
- · Class III and V restorations
- · Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- · Repair of small defects in aesthetic indirect restorations
- Pit and fissure sealant
- · Blocking out of undercuts
- · Repair of resin and acrylic temporary materials
The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.
Infinix™ Bulk Fill Flow Composite
- · Base under Class I and II direct restorations
- · Liner under direct restorative materials
- · Pit and fissure sealant
- · Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- · Class III and V restorations
- · Blocking out of undercuts
- Repair of small enamel defects
- · Repair of small defects in esthetic indirect restorations
- · Repair of resin and acrylic temporary materials
• As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown
The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.
Product codes (comma separated list FDA assigned to the subject device)
EBF
Device Description
Composite restorations are performed with two main components: a resin-based composite for filling the prepared tooth cavity and the bonding system which is applied to the cavity before the placement of the composite filling material.
The composites are resin based and the proportion of the inorganic filler material is the main differentiator among the composite materials.
The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:
- . Universal Composite
- Flowable Composite
- . Bulk Fill Flow Composite
There are no changes to the formulation, manufacturing processes, and packaging of the three composites submitted under K182921, K182714, and K182580.
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Performance Testing: An in-situ clinical study comparing Infinix™ Universal Composite to a widely used, similar composite without antibacterial particles was conducted at the School of Dentistry, UCSF (San Francisco, CA). Subjects wearing lower partial dentures with acrylic flanges on both sides of the mouth who met the eligibility criteria were recruited. On each side of the denture an enamel slab was placed next to a composite, separated by a tiny gap. On one side of the denture the composite was Nobio's Infinix Universal Composite ("Nobio group"), on the other side a widely used, similar composite without antibacterial particles served as control material ("control group"). Enamel slab and composite were recessed into the flange, allowing microbial plaque to accumulate on top of it and especially in the gap. After wearing the dentures for four weeks with the slabs, decalcification (mineral loss) in the enamel slabs adjacent to the gap were determined by cross-section microhardness testing in the laboratory. Average mineral loss was calculated for the Nobio group and the control group, and difference tested for statistical significance.
A total of 25 subjects, 17 males and 8 females, were recruited having an average age of 63.7 ± 14.1 years (range 33.66 to 80.98 years) and their ethnicity included 12 subjects (48%) white and 13 subjects (52%) non-white (7 Black, 3 Hispanic, 2 Asian, and 1 Native American). The subjects wore the gap models in average for 27.9 ± 1.2 days (range 26 to 31 days), thus meeting the targeted 4-week in situ wearing period. The average mineral loss ΔZ (vol% x um) in enamel slabs facing the control composite was 730.8 ± 558 while the average mineral loss ΔZ in enamel slabs facing the Nobio composite with antibacterial particles was 233.8 ± 330.9. The two-tailed, paired t-test determined the significance level for a difference as P
§ 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.
0
Image /page/0/Picture/0 description: The image contains 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 is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 14, 2020
Nobio Ltd. % Shoshan (Shosh) Friedman Senior Regulatory Consultant ProMedoss, Inc. 3521 Hatwynn Rd. Charlotte, North Carolina 28269
Re: K201010
Trade/Device Name: Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: April 14, 2020 Received: April 17, 2020
Dear Shoshan (Shosh) Friedman:
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.
1
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.
for Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K201010
Device Name Infinix™ Universal Composite
Indications for Use (Describe)
- · Restorations in the posterior region (Class I and II)
- · Anterior restorations (Class III, IV)
- · Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- · Veneering of discolored anterior teeth
- · Splinting of mobile teeth
- Extended fissure sealing in molars and premolars
- · Repair of composite/ceramic veneers
The addition of the QASi particles to the Infinix™ Universal Composite reduces demineralization, which is part of the caries-formation process.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Registration (Per 49 CFR 390.21 when Change) | One-Time Notification (Per 49 CFR 390.19) |
|---|---|
| ------------------------------------------------------------------------------------------------------------------------------ | ------------------------------------------------------------------------------------------------------------ |
|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."
3
Indications for Use
510(k) Number (if known) K201010
Device Name Infinix™ Flowable Composite
Indications for Use (Describe)
- · Class III and V restorations
- · Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- As base/liner under direct or indirect restorations
- · Repair of small defects in aesthetic indirect restorations
- Pit and fissure sealant
- · Blocking out of undercuts
- · Repair of resin and acrylic temporary materials
The addition of the QASi particles to the Infinix™ Flowable Composite reduces demineralization, which is part of the caries-formation process.
| 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
Indications for Use
510(k) Number (if known) K201010
Device Name Infinix™ Bulk Fill Flow Composite
Indications for Use (Describe)
- · Base under Class I and II direct restorations
- · Liner under direct restorative materials
- · Pit and fissure sealant
- · Restoration of minimally invasive cavity preparations (including small, non-stress-bearing occlusal restorations)
- · Class III and V restorations
- · Blocking out of undercuts
- Repair of small enamel defects
- · Repair of small defects in esthetic indirect restorations
- · Repair of resin and acrylic temporary materials
• As a core build-up where at least half the coronal tooth structure is remaining to provide structural support for the crown The addition of the OASi particles to the Infinix™ Bulk Fill Flow Composite reduces demineralization, which is part of the caries-formation process.
| 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."
5
510(K) SUMMARY [as required by section 807.92(c)] Infinix™ Family of Dental Composites 510(k) Number K201010
5.1 SUBMITTER
Applicant's Name:
Nobio Ltd. 8 Hamatechet St. POB 50502 Kadima, Israel 6092000 Phone: +972-3-9059966
Contact Person:
Shoshana (Shosh) Friedman Senior Regulatory Consultant 3521 Hatwynn Rd. Charlotte, NC 28269 Phone: 704-430-8695 s.friedman@promedoss.com
Date Prepared:
August 7, 2020
5.2 DEVICE
Trade Name:
Infinix™ Family of Dental Composites which includes:
- Infinix™ Universal Composite
- Infinix™ Flowable Composite ●
- Infinix™ Bulk Fill Flow Composite
Classification: Name: Material, Tooth Shade, Resin Product Code: EBF Regulation No: 872.3690 Class: 2 Review Panel: Dental
5.3 PREDICATE DEVICES
- K182921 InfinixTM Universal Composite (previously called Novidia™ Universal Composite)
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- K182580 InfinixTM Flowable Composite (previously called Novidia™ Flowable ● Composite)
- K182714 Infinix™ Bulk Fill Flow Composite (previously called Novidia™ Bulk ● Fill Flow Composite)
5.4 DEVICE DESCRIPTION
Composite restorations are performed with two main components: a resin-based composite for filling the prepared tooth cavity and the bonding system which is applied to the cavity before the placement of the composite filling material.
The composites are resin based and the proportion of the inorganic filler material is the main differentiator among the composite materials.
The Infinix™ Family of Dental Composites include the following light-cured, resinbased composite materials:
- . Universal Composite
- Flowable Composite
- . Bulk Fill Flow Composite
There are no changes to the formulation, manufacturing processes, and packaging of the three composites submitted under K182921, K182714, and K182580.
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the Infinix™ composites are decorated with quaternary ammonium functional groups that are covalently bound to the filler particles' silica core via a silane linker (herein referred to as "QASi"). Following light induced polymerization, QASi particles (produced by Nobio) remain permanently entrapped within the composite restoration and destroy microorganisms by contact. As the cell membrane of microorganisms is negatively charged and the QASi particles have strong positive charges, microorganisms are electrostatically attracted to the positively charged cured material's surface resulting in disruption of their cell membrane and immediate microbial lysis.
5.5 INDICATIONS FOR USE
The indications for Use of the Infinix™ Family of Dental Composites is substantially similar to these of their predicate devices with the exception of the inclusion of an antimicrobial claim based on data collected from in situ clinical study.
| Subject Devices | Predicate Devices |
|---|---|
| Infinix™ Universal Composite | Infinix™ Universal Composite (K182921) |
| • Restorations in the posterior region | |
| (Class I and II) | • Restorations in the posterior region (Class I |
| and II) | |
| • Anterior restorations (Class III, IV) | • Anterior restorations (Class III, IV) |
| • Class V restorations (cervical caries, | |
| root erosion, wedge-shaped defects) | • Class V restorations (cervical caries, root |
| erosion, wedge-shaped defects) | |
| • Veneering of discolored anterior teeth | • Veneering of discolored anterior teeth |
| • Splinting of mobile teeth | • Splinting of mobile teeth |
| • Extended fissure sealing in molars and | • Extended fissure sealing in molars and |
| premolars | premolars |
| • Repair of composite/ceramic veneers | • Repair of composite/ceramic veneers |
| The addition of the QASi particles to the | |
| Infinix™ Universal Composite reduces | |
| demineralization, which is part of the | |
| caries-formation process. | |
| Infinix™ Flowable Composite | Infinix™ Flowable Composite (K182580) |
| • Class III and V restorations | • Class III and V restorations |
| • Restoration of minimally invasive | • Restoration of minimally invasive |
| cavity preparations (including small, | cavity preparations (including small, |
| non-stress-bearing occlusal | non-stress-bearing occlusal |
| restorations) | restorations) |
| • As base/liner under direct or indirect | • As base/liner under direct or indirect |
| restorations | restorations |
| • Repair of small defects in esthetic | • Repair of small defects in esthetic |
| indirect restorations | indirect restorations |
| • Pit and fissure sealant | • Pit and fissure sealant |
| • Blocking out of undercuts | • Blocking out of undercuts |
| • Repair of resin and acrylic temporary | • Repair of resin and acrylic temporary |
| materials | materials |
| The addition of the QASi particles to the | |
| Infinix™ Flowable Composite reduces | |
| demineralization, which is part of the | |
| caries-formation process. | |
| Infinix™ Bulk Fill Flow Composite | Infinix™ Bulk Fill Flow Composite (K182714) |
| • Base under Class I and II direct | • Base under Class I and II direct |
| restorations | restorations |
| • Liner under direct restorative materials | • Liner under direct restorative materials |
| • Pit and fissure sealant | • Pit and fissure sealant |
| • Restoration of minimally invasive | • Restoration of minimally invasive |
| cavity preparations (including small, | cavity preparations (including small, |
| non-stress-bearing occlusal | non-stress-bearing occlusal |
| restorations) | restorations) |
| • Class III and V restorations | • Class III and V restorations |
| • Blocking out of undercuts | • Blocking out of undercuts |
| • Repair of small enamel defects | • Repair of small enamel defects |
| • Repair of small defects in esthetic | • Repair of small defects in esthetic |
| indirect restorations | indirect restorations |
| • Repair of resin and acrylic temporary | • Repair of resin and acrylic temporary |
| materials | materials |
| • As a core build-up where at least half | • As a core build-up where at least half |
| the coronal tooth structure is remaining | |
| to provide structural support for the | |
| crown | |
| The addition of the QASi particles to the | |
| InfinixTM Bulk Fill Flow Composite | |
| reduces demineralization, which is part of | |
| the caries-formation process. | to provide structural support for the |
| crown |
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5.6 SUBSTANTIAL EQUIVALENCE
The Infinix™ Universal Composite, Infinix™ Flowable Composite, and InfinixTM Bulk Fill Flow Composite have the exact same formulation, manufacturing processes, and packaging as the three composites submitted under K182921, K182714, and K182580. The only differences implemented in this submission are:
-
- Removal from the Instructions for Use the statement "Clinical studies have not been conducted to demonstrate that the presence of QASi in this device results in improved clinical outcomes" that was requested by the Agency in the previous 510(k) submissions; and
-
- Addition of the following statement to the intended use of each composite: "The addition of the QASi particles to the { composite name } reduces demineralization, which is part of the caries-formation process."
5.7 PERFORMANCE DATA
Non-Clinical Performance Testing:
All non-clinical and biological testing submitted in K182921, K182714, and K182580 apply to this submission as no changes have been implemented in the formulation, manufacturing processes, and packaging.
Clinical Performance Testing:
An in-situ clinical study comparing Infinix™ Universal Composite to a widely used, similar composite without antibacterial particles was conducted at the School of Dentistry, UCSF (San Francisco, CA). Subjects wearing lower partial dentures with acrylic flanges on both sides of the mouth who met the eligibility criteria were recruited. On each side of the denture an enamel slab was placed next to a composite, separated by a tiny gap. On one side of the denture the composite was Nobio's Infinix Universal Composite ("Nobio group"), on the other side a widely used, similar composite without antibacterial particles served as control material ("control group"). Enamel slab and composite were recessed into the flange, allowing microbial plaque to accumulate on top of it and especially in the gap. After wearing the dentures for four weeks with the slabs, decalcification (mineral loss) in the enamel slabs adjacent to the gap were determined by cross-section microhardness testing in the laboratory. Average mineral loss was calculated for the Nobio group and the control group, and difference tested for statistical significance.
A total of 25 subjects, 17 males and 8 females, were recruited having an average age of 63.7 ± 14.1 years (range 33.66 to 80.98 years) and their ethnicity included 12 subjects
9
(48%) white and 13 subjects (52%) non-white (7 Black, 3 Hispanic, 2 Asian, and 1 Native American). The subjects wore the gap models in average for 27.9 ± 1.2 days (range 26 to 31 days), thus meeting the targeted 4-week in situ wearing period. The average mineral loss ΔZ (vol% x um) in enamel slabs facing the control composite was 730.8 ± 558 while the average mineral loss ΔZ in enamel slabs facing the Nobio composite with antibacterial particles was 233.8 ± 330.9. The two-tailed, paired t-test determined the significance level for a difference as P