(1 days)
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite K201010
No
The device description focuses on the material properties and chemical composition of the sealant, with no mention of AI or ML technologies. The performance studies are based on standard biocompatibility and bench testing, not algorithmic performance.
No.
The device is indicated for prophylactic sealing of pits and fissures and does not claim to treat or cure a disease or condition.
No
This device is a sealant used for prophylactic sealing of pits and fissures, which is a treatment or preventive measure, not a diagnostic one.
No
The device description clearly indicates that the device is a physical dental sealant material (methacrylate-based resin) with added filler particles. It is not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the prophylactic sealing of pits and fissures in teeth and as a flowable composite. This is a direct treatment/preventative measure applied to the patient's body.
- Device Description: The device is a resin sealant/flowable composite that is light-cured and applied to the tooth surface. It contains particles that physically interact with microorganisms on contact.
- Lack of In Vitro Testing: The description of the performance studies focuses on biocompatibility and bench testing of the material properties (depth of cure, strength, etc.). There is no mention of testing patient samples (blood, urine, tissue, etc.) to diagnose or monitor a condition.
- No Mention of Analyzing Samples: The device description and intended use do not involve analyzing samples taken from the human body.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, prevention, or treatment of a disease or condition. This device is applied directly to the patient's teeth for a preventative and restorative purpose.
N/A
Intended Use / Indications for Use
UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
Product codes
EBC, EBF
Device Description
UltraSeal XT plus bioprotection by Nobio sealant and flowable composite – UltraSeal XT plus sealant is a 58% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is used with PrimaDry drying and priming agent to aid in avoiding moisture contamination which can cause microleakage and poor retention. It is a Type 1 Class 2 Group 1 polymer-based dental restorative flowable resin which is suitable for occlusal surfaces. It can be used where the use of a flowable is indicated. It is compatible with adhesives and bonding agents. UltraSeal XT plus sealant has a radiopacity value of 1.44 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material (having a radiopacity equivalent to 1 mm of aluminum) has a radiopacity equivalent to that of dentin-and 2 mm of aluminum is equivalent to enamel. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
The dimensions of filler particles are as follows:
| Component | Particle size (μm) |
|---|---|
| Aluminum Oxide | ≤ 0.05 |
| Glass | 1.5 ± 0.25 |
The percentage by volume of filler particles is 33% (total fillers, 19.2 mL/total volume, 57.90 mL* 100)
| UltraSeal XT plus sealant shade | VITA 3D-MASTER®* Shade Guide |
|---|---|
| A2 Opaque | A2 |
UltraSeal XT hydro bioprotection by Nobio sealant – UltraSeal XT hydro sealant is a Class 2, 53% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is partly hydrophobic and hydrophilic before it is cured, hydrophobic once cured, and has a selfadhesive quality. UltraSeal XT hydro sealant chemistry provides the option of a visual verification for marginal retention-with the use of a black light upon placement and at recall visits. The UV light is not included in the UltraSeal XT hydro sealant kit. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio 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 sealant 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.
Both subject devices have a depth of cure ≥ 1.5mm, are curable at wavelengths of 385-515nm and will remain uncured after light exposure while in their primary container. UltraSeal XT plus Bioprotection by Nobio is also indicated for use as a flowable composite. It has a flexural strength of ≥ 80 MPa, Water Sorption ≤ 40 µ g/mm3, Water Solubility ≤ 7.5 µ g/mm3, Radio-Opacity, ≥ 1mm of Al, Surface Hardness ≥ 20 HK and Ambient light sensistivity resulting in the product being physically homogeneous after 60 seconds.
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
Licensed Dentist or Dental Professional
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)
Non-clinical and biological testing was completed to assess the performance and biocompatibility of the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio and to support substantial equivalence. The data provided in this 510(k) submission shows that the sealant is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing per ISO 4049 and ISO 6874. The list of these tests is provided in Table 5-1.
Biocompatibility:
Chemical Characterization
MEM Elution Assay
Guinea Pig Maximization Sensitization
Oral Mucosal Irritation Test
Bench Testing:
UltraSeal XT plus Bioprotection by Nobio
Depth of Cure
Curable at Wavelengths 385-515 nm
Flexural Strength
Ambient Light Sensitivity
Water Sorption
Water Solubility
Radio-opacity
Knoop Hardness
Opaque Delivery System
Medium Viscosity Liquid
Fluoride Release
Hydrophobic Components
Shade and Color
Inclusion of Nobio QASi Particles
UltraSeal XT hydro Bioprotection by Nobio
Depth of Cure
Curable at Wavelengths 385-515 nm
Opaque Delivery System
Fluoride Release
Fluorescing Agent
Shade and Color
Hydrophilic Components
Inclusion of Nobio QASi Particles
Safety is further proven by testing conducted to ISO 10993-1 and ISO 7405 supporting the biological safety of the devices. Lastly, device efficacy is met with clinical acceptance as being an effective pit and fissure sealant and as a flowable restorative (UltraSeal XT plus Bioprotection by Nobio only) through simulated use testing with representative users.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
UltraSeal XT plus K993846, UltraSeal XT hydro K112517
Reference Device(s)
Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite K201010
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3765 Pit and fissure sealant and conditioner.
(a)
Identification. A pit and fissure sealant and conditioner is a device composed of resin, such as polymethylmethacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.(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 18, 2023
Ultradent Product, Inc. % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K232498
Trade/Device Name: UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio Regulation Number: 21 CFR 872.3765 Regulation Name: Pit and fissure sealant and conditioner Regulatory Class: Class II Product Code: EBC, EBF Dated: August 14, 2023 Received: August 17, 2023
Dear Dave Yungvirt:
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
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 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 -S
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
2
Indications for Use
510(k) Number (if known) K232498
Device Name UltraSeal XT plus Bioprotection by Nobio UltraSeal XT hydro Bioprotection by Nobio
Indications for Use (Describe)
UltraSeal XT plus bioprotection by Nobio sealant - UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
UltraSeal XT hydro bioprotection by Nobio sealant - Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
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) |
|---|---|
| --------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------- |
|X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
K232498
510(k) Summary
This summary of the 510(k) substantial equivalence information is being submitted in accordance with the requirements of 21 CFR 807.92 UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT plus Bioprotection by Nobio.
I. Applicant's Name and Address
Ultradent Product, Inc. 505 West Ultradent Drive (10200 South) South Jordan, UT 84095
| Contact Person: | Ruth Gardner |
|---|---|
| Title: | Regulatory Affairs Specialist II |
| Telephone: | 801-553-4431 |
| Fax: | 801-553-4609 |
| Date Summary Prepared: | July 31, 2023 |
II. Name of the Device
| Device: | Pit and fissure sealant and conditioner |
|---|---|
| Trade/Device Name: | UltraSeal XT plus Bioprotection by Nobio |
| UltraSeal XT hydro Bioprotection by Nobio | |
| Common Name: | Sealant, pit and fissure, and conditioner |
| Material, Tooth Shade, Resin | |
| Review Panel: | Dental |
| Regulation Number: | 21 CFR 872.3765 |
| Device Class: | Class II |
| Classification Product Code: | EBC, EBF |
III. Device Description
UltraSeal XT plus bioprotection by Nobio sealant and flowable composite – UltraSeal XT plus sealant is a 58% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is used with PrimaDry drying and priming agent to aid in avoiding moisture contamination which can cause microleakage and poor retention. It is a Type 1 Class 2 Group 1 polymer-based dental restorative flowable resin which is suitable for occlusal surfaces. It can be used where
4
the use of a flowable is indicated. It is compatible with adhesives and bonding agents. UltraSeal XT plus sealant has a radiopacity value of 1.44 mm of aluminum. Aluminum has a radiopacity equivalent to that of dentin. Thus, 1 mm of material (having a radiopacity equivalent to 1 mm of aluminum) has a radiopacity equivalent to that of dentin-and 2 mm of aluminum is equivalent to enamel. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
The dimensions of filler particles are as follows:
| Component | Particle size
(μm) |
|----------------|-----------------------|
| Aluminum Oxide | ≤ 0.05 |
| Glass | 1.5 ± 0.25 |
The percentage by volume of filler particles is 33% (total fillers, 19.2 mL/total volume, 57.90 mL* 100)
| UltraSeal XT plus
sealant shade | VITA 3D-MASTER®*
Shade Guide |
|------------------------------------|---------------------------------|
| A2 Opaque | A2 |
*Not a registered trademark of Ultradent Products, Inc.
UltraSeal XT hydro bioprotection by Nobio sealant – UltraSeal XT hydro sealant is a Class 2, 53% filled, light-cured, radiopaque, methacrylate-based, thixotropic resin sealant. It is partly hydrophobic and hydrophilic before it is cured, hydrophobic once cured, and has a selfadhesive quality. UltraSeal XT hydro sealant chemistry provides the option of a visual verification for marginal retention-with the use of a black light upon placement and at recall visits. The UV light is not included in the UltraSeal XT hydro sealant kit. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
Some of the silica-based filler particles (max 1.2% wt/wt of the total formulation) contained in all the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio 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
sealant 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.
Both subject devices have a depth of cure ≥ 1.5mm, are curable at wavelengths of 385-515nm and will remain uncured after light exposure while in their primary container. UltraSeal XT plus Bioprotection by Nobio is also indicated for use as a flowable composite. It has a flexural
5
strength of ≥ 80 MPa, Water Sortpion ≤ 40 µ g/mm3, Water Solubility ≤ 7.5 µ g/mm3, Radio-Opacity, ≥ 1mm of Al, Surface Hardness ≥ 20 HK and Ambient light sensistivity resulting in the product being physically homogeneous after 60 seconds.
IV. Statement of Intended Use
UltraSeal XT plus bioprotection by Nobio sealant – UltraSeal XT plus sealant for prophylactic sealing of pits and fissures and can be used where the use of a flowable composite is indicated. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
UltraSeal XT hydro bioprotection by Nobio sealant – Use UltraSeal XT hydro sealant for prophylactic sealing of pits and fissures. The addition of the bioprotection by Nobio reduces demineralization, which is part of the caries formation process.
V. Predicate Device
| Predicate Identified: | UltraSeal XT plus K993846 |
|---|---|
| UltraSeal XT hydro K112517 | |
| Infinix Universal Composite, Infinix Flowable Composite, | |
| Infinix Bulk Fill Flow Composite K201010 |
VII. Comparison of Technological Characteristics
Predicate technological comparison:
The technology, delivery, and intended use of UltraSeal XT plus bioprotection by Nobio and UltraSeal XT hydro bioprotection by nobio are substantially equivalent to the identified predicate as outlined in Table 5-1:
6
Table 5-1
UltraSeal XT plus Bioprotection by Nobio:
| Descriptive
Information/
characteristic | Device:
UltraSeal XT plus bioprotection by
Nobio | Predicate: UltraSeal XT plus (K993846) | Identified Characteristic Differences and
Rationale for Differences |
|-----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Product Code | EBC
EBF | EBC | Same |
| Indications for
Use | UltraSeal XT plus sealant for prophylactic
sealing of pits and fissures and can be
used where the use of a flowable
composite is indicated. The addition of the
bioprotection by Nobio reduces
demineralization, which is part of the
caries formation process. | UltraSeal XT plus sealant for prophylactic
sealing of pits and fissures and can be used
where the use of a flowable composite is
indicated. | Similar - Subject device introduces the Nobio
QASi particles. |
| Recognized
Standards | ISO 6874
ISO 4049
ISO 13485
ISO 14971
ISO 10993 Series
ISO 7405
IEC 62366-1 | ISO 6874
ISO 4049
ISO 13485
ISO 14971
ISO 10993 Series
ISO 7405
IEC 62366-1 | Similar |
| Intended User | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same |
| Characteristics | • Prophylactic sealing of pits and Fissures
• Flowable, light cured material.
• Nobio QASi Antimicrobial technology | • Prophylactic sealing of pits and Fissures
• Flowable, light cured material. | Similar - Subject device introduces the Nobio
QASi particles. |
| Composition | • Methacrylates
• Anti-Bacterial (QASi particles)
• Photo-initiators | • Methacrylates
• Photo-initiator
• Glass fillers | Similar - Subject device introduces the Nobio
QASi particles. |
| | • Source of fluoride
• Glass filler
• Colorant | • Colorant
Source of fluoride | |
| Delivery System
or Deployment
Methods | Syringe with tip | Syringe with tip | Same |
| Physical
Properties | • Pit & Fissure Sealant, Flowable Composite | • Pit & Fissure Sealant, Flowable Composite | Same |
| | • Depth of cure $≥ 1.5mm$ | • Depth of cure $≥ 1.5 mm$ | Same |
| | • Curable at wavelengths of 385-515 nm | • Cures with wavelengths of 385 – 515 nm | Similar |
| | • Curing Intensity $≥ 800 mW/cm2$ | • Curing Intensity $≥ 800 mW/cm2$ | Similar |
| | • Curing time 10 seconds | • Curing time 10 seconds | Same |
| | • ISO 4049:2019 | • ISO 4049:2019 | Similar |
| | • ISO 4049:2019 - Flexural Strength | • ISO 4049:2019 - Flexural strength | Similar |
| | • Filler Particle Size: Aluminum Oxide $≤ 0.05μm$ | • Filler Particle Size: Aluminum Oxide $≤ 0.05μm$ | Similar, filler differences contribute to
handling and usability differences in products |
| | • Glass $1.5 ± 0.25μm$ | • Glass $1.5 ± 0.25μm$ | |
| | • QASi antibacterial Nano Fillers | | |
| | • Water sorption - ISO 4049:2019 | • Water sorption - ISO 4049:2019 | Similar |
| | • Water solubility - ISO 4049:2019 | • Water solubility – ISO 4049:2019 | Similar |
| | • Radio-Opacity - ISO 4049:2019 | • Radio-opacity - ISO 4049:2019 | Similar |
| | • Surface Hardness $≥ 20 HK$ | • Surface hardness $≥ 20 HK$ | Similar – Reference device value is unknown |
| | • Fluoride releasing | • Fluoride releasing | The subject device and predicate device are both fluoride releasing. The reference device does not include fluoride |
| | • Nobio QASi particles | • N/A | Similar – the subject device includes the Nobio QASi particles |
| | • Shade: A2 Opaque shade (off-white to light yellow) | • Shades: Opaque White, Clear, A1, A2 | Similar |
| | • Hydrophobic | • Hydrophobic | Similar |
| Biocompatibility
and Safety | Tested per ISO 7405, ISO 10993-1
• Physical/Chemical Information
• Cytotoxicity
• Sensitization
• Irritation
• Acute System Toxicity
• Subacute Systemic Toxicity
• Genotoxicity
• Implantation Effects | Tested per ISO 7405, ISO 10993-1
• Cytotoxicity
• Sensitization
• Mutagenicity | UltraSeal XT plus Bioprotection by Nobio, predicate and reference device is shown to be biocompatible. |
7
8
9
UltraSeal XT hydro Bioprotection by Nobio:
| Descriptive
Information/
characteristic | UltraSeal XT hydro bioprotection by
Nobio | Predicate: UltraSeal XT hydro (K112517) | Identified Characteristic Differences and
Rationale for Differences |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Product Code | EBC | EBC | Same |
| Indications for
Use | Use UltraSeal XT hydro sealant for
prophylactic sealing of pits and fissures.
The addition of the bioprotection by
Nobio reduces demineralization, which is
part of the caries formation process. | Use UltraSeal XT hydro sealant for prophylactic
sealing of pits and fissures. | Similar - Subject device introduces the Nobio
QASi particles. |
| Recognized
Standards | ISO 6874
ISO 13485
ISO 14971
ISO 10993 Series
ISO 7405
IEC 62366-1 | ISO 6874
ISO 13485
ISO 14971
ISO 10993
ISO 7405
IEC 62366-1 | Similar |
| Intended User | Licensed Dentist or Dental Professional | Licensed Dentist or Dental Professional | Same. |
| Characteristics | • Prophylactic sealing of pits and Fissures
• Nobio QASi Antimicrobial technology | • Prophylactic sealing of pits and Fissures | Similar - Subject device introduces the Nobio
QASi particles. |
| Composition | • Methacrylates
• Anti-Bacterial (QASi particles)
• Lowering pH
• Photo-initiator
• Source of fluoride
• Colorant
• Glass filler | • Methacrylates
• Photo-initiator
• Glass fillers
• Colorant
• Source of fluoride | Similar - Subject device introduces the Nobio
QASi particles. |
| Delivery System
or Deployment
Methods | Syringe with tip | Syringe with tip | Same |
| Physical
Properties | • Pit & Fissure Sealant | • Pit & Fissure Sealant | Same |
| | • Depth of cure ≥ 1.5mm | • Depth of Cure ≥ 1.5 mm | Same |
| | • Curable at wavelengths of 385-515 nm | • Curable at wavelengths of 385-515 nm | Similar |
| | • Curing Time 10 seconds | • Curing Time 10 seconds | Same |
| | • Nobio QASi particles | • N/A | Similar - the subject device includes the Nobio
QASi particles |
| | • Fluoresces | • Fluoresces | The subject and predicate device have a
fluorescing feature. The reference device does
not. |
| | • Curing Intensity ≥ 800 mW/cm2 | • Curing Intensity ≥ 800 mW/cm2 | Similar |
| | • Shade: A2 Opaque shade (off-white to
light yellow) | • Shades: Opaque White, and Natural
Shades | Similar |
| | • Hydrophilic | • Hydrophilic | Similar |
| Biocompatibility
and Safety | Tested per ISO 7405, ISO 10993-1
• Physical/Chemical Information
• Cytotoxicity
• Sensitization
• Irritation
• Acute System Toxicity
• Subacute Systemic Toxicity
• Genotoxicity
• Implantation Effects | Tested per ISO 7405, ISO 10993-1
•Irritation
•Cytotoxicity
•Sensitization
•Mutagenicity | UltraSeal XT plus Bioprotection by Nobio,
predicate and reference device is shown to be
biocompatible. |
10
11
VIII Non-Clinical Performance Testing:
Non-clinical and biological testing was completed to assess the performance and biocompatibility of the UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio and to support substantial equivalence. The data provided in this 510(k) submission shows that the sealant is biocompatible based on the biocompatibility assessment conducted as per ISO 10993 and ISO 7405 and performs as intended based on the bench testing per ISO 4049 and ISO 6874. The list of these tests is provided in Table 5-1.
| Biocompatibility: |
|---|
| Chemical Characterization |
| MEM Elution Assay |
| Guinea Pig Maximization Sensitization |
| Oral Mucosal Irritation Test |
| Bench Testing: |
| UltraSeal XT plus Bioprotection by Nobio |
| Depth of Cure |
| Curable at Wavelengths 385-515 nm |
| Flexural Strength |
| Ambient Light Sensitivity |
| Water Sorption |
| Water Solubility |
| Radio-opacity |
| Knoop Hardness |
| Opaque Delivery System |
| Medium Viscosity Liquid |
| Fluoride Release |
| Hydrophobic Components |
| Shade and Color |
| Inclusion of Nobio QASi Particles |
| UltraSeal XT hydro Bioprotection by Nobio |
| Depth of Cure |
| Curable at Wavelengths 385-515 nm |
| Opaque Delivery System |
| Fluoride Release |
| Fluorescing Agent |
| Shade and Color |
| Hydrophilic Components |
| Inclusion of Nobio QASi Particles |
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Conclusion:
The predicate and subject devices have identical indications for use with a slight variation highlighting the inclusion of the Nobio QASi particles that reduces demineralization. Reference device, Infinix Flowable composite (K201010), intended for use as a flowable composite and/or pit and fissure sealant, incorporates the same Nobio QASi particles that reduces demineralization. Like the predicate devices, the subject devices utilized ISO 6874 and ISO 4049 to evaluate performance aspects of the devices. Safety is further proven by testing conducted to ISO 10993-1 and ISO 7405 supporting the biological safety of the devices. Lastly, device efficacy is met with clinical acceptance as being an effective pit and fissure sealant and as a flowable restorative (UltraSeal XT plus Bioprotection by Nobio only) through simulated use testing with representative users. As such, the differences in indications for use between the predicate and subject devices does not impact safety or effectiveness of the devices.
Based on this, the similar intended use and testing information presented above for the predicate products, UltraSeal XT plus and UltraSeal XT hydro, and the subject products, UltraSeal XT plus Bioprotection by Nobio and UltraSeal XT hydro Bioprotection by Nobio, are substantially equivalent.