(98 days)
Conventional application (Light intensity ≤2,000 mW/cm2):
- Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Reconstructive build-ups
- Restoration of deciduous teeth
Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2): - Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect
Tetric® PowerFill is a light-curing radiopaque resin-based composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (< 1.0 wt%). While using the 3sCure mode of Bluephase Power-Cure (3.050mW/cm2), the material can be cured within 3 seconds. The material is available in syringes and cavifils.
The provided text describes a 510(k) premarket notification for a dental restorative material called "Tetric® PowerFill." This document focuses on demonstrating that the new device (Tetric® PowerFill) is substantially equivalent to a legally marketed predicate device (Tetric EvoCeram Bulk Fill).
The acceptance criteria and study proving the device meets these criteria in the context of this document are related to bench testing of physical properties and biocompatibility, not a study involving human or AI readers or ground truth established by experts as would be common for diagnostic AI/ML devices.
Here's a breakdown of the information based on the provided text:
1. A table of acceptance criteria and the reported device performance:
The document states that "Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, curing depth, sensitivity to light, wavelength for curing, water sorption and water solubility and radiopacity according to ISO 4049:2009." It also mentions "The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent."
It also states that "The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2008 and ISO 14971:2012. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009 and Genotoxicity according to EN ISO10993-3:2014 and the device was found to be non-cytotoxic and nongenotoxic."
While specific numerical acceptance criteria and performance data values are not explicitly provided in the text, the table below summarizes the types of criteria and the qualitative reported performance as stated.
| Acceptance Criteria (Physical Properties) | Reported Device Performance (Tetric® PowerFill) |
|---|---|
| Flexural strength | Results show substantial equivalence to predicate device. |
| Curing depth | Results show substantial equivalence to predicate device. |
| Sensitivity to light | Results show substantial equivalence to predicate device. |
| Wavelength for curing | Results show substantial equivalence to predicate device. |
| Water sorption | Results show substantial equivalence to predicate device. |
| Water solubility | Results show substantial equivalence to predicate device. |
| Radiopacity | Results show substantial equivalence to predicate device. |
| Acceptance Criteria (Biocompatibility) | Reported Device Performance (Tetric® PowerFill) |
| Cytotoxicity (according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009) | Non-cytotoxic |
| Genotoxicity (according to EN ISO10993-3:2014) | Non-genotoxic |
| Irritation (literature review) | Benefits exceed potential risks, supporting substantial equivalence. |
| Delayed-type hypersensitivity/Sensitization (literature review) | Benefits exceed potential risks, supporting substantial equivalence. |
| Systemic toxicity (literature review) | Benefits exceed potential risks, supporting substantial equivalence. |
| Implantation (literature review) | Benefits exceed potential risks, supporting substantial equivalence. |
| Pulp and dentine usage (literature review) | Benefits exceed potential risks, supporting substantial equivalence. |
2. Sample sized used for the test set and the data provenance:
This information is not provided in the given text as it pertains to a mechanical/chemical testing of a dental material, not a clinical study with a "test set" in the context of imaging or AI. The testing is described as "bench testing" and "evaluated based on a review of the literature."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the ground truth for physical and biocompatibility properties of a dental resin is established through standardized laboratory testing (e.g., ISO standards), not by human expert interpretation of images or other clinical data.
4. Adjudication method for the test set:
This information is not applicable for the reasons stated above.
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:
This information is not applicable as this document is for a dental restorative material, not an AI/ML diagnostic device that would involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable as this document is for a dental restorative material, not an AI/ML algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
The ground truth for the physical properties (flexural strength, curing depth, etc.) is established by standardized laboratory testing methods prescribed by ISO 4049:2009. For biocompatibility, the ground truth for cytotoxicity and genotoxicity is established by ISO 10993-5:2009 and EN ISO10993-3:2014 respectively, while other biocompatibility aspects (irritation, sensitization, systemic toxicity, implantation, pulp and dentin usage) were evaluated based on a review of scientific literature.
8. The sample size for the training set:
This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established:
This information is not applicable as this document is for a dental restorative material undergoing physical and biocompatibility testing, not an AI/ML device requiring a training set.
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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, featuring a stylized human figure. To the right is the FDA logo, with the letters "FDA" in a blue square, followed by "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Ivoclar Vivadent, AG % Lori Aleshin Director of Quality & Regulatory Affairs Ivoclar Vivadent, Inc. 175 Pineview Drive Amherst, New York 14228
Re: K183380
Trade/Device Name: Tetric® PowerFill Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 21, 2018 Received: December 26, 2018
Dear Lori Aleshin:
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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
March 14, 2019
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Mary Mary S. = Mary 3. S. Runner -S3
Date: 2019.03.14 09:38:49
-04'00' - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183380
Device Name Tetric® PowerFill
Indications for Use (Describe)
-
Conventional application (Light intensity ≤2,000 mW/cm2):
-
Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
-
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
-
Reconstructive build-ups
-
Restoration of deciduous teeth
-
Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2):
-
Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect
| 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)
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Image /page/3/Picture/1 description: The image shows the logo for Ivoclar Vivadent. The logo is composed of the company name in a bold, sans-serif font, with the words "passion vision innovation" written in a smaller font below. Above the company name is an arc of green and blue dots and squares. The green dots are on the left side of the arc, and the blue squares are on the right side of the arc.
| Contact: | Lori Aleshin, Director of Quality and Regulatory AffairsIvoclar Vivadent, Inc.175 Pineview DriveAmherst, New York 14228716-691-2045lori.aleshin@ivoclarvivadent.com |
|---|---|
| Company: | Ivoclar Vivadent, AGBendererstrasse 2, Schaan, FL-9494, Liechtenstein+423-235-3535 |
| Date Prepared: | December 4, 2018 |
| Proprietary Name: | Tetric® PowerFill |
| Classification Name: | Material, Tooth Shade, Resin (872.3690)(Classification Code EBF) |
| Predicate Device: | Tetric EvoCeram Bulk Fill (K111958) by Ivoclar Vivadent |
Tetric® PowerFill is a light-curing radiopaque resin-based Device Description: composite for the direct restorative treatment in posterior teeth. Tetric PowerFill cures with light in the wavelength range of 400-500 nm and can be applied in layers of up to 4 mm. The monomer matrix is composed of dimethacrylates (20-21 wt%). The fillers contain barium glass, ytterbium trifluoride, mixed oxide and copolymer (79-80 wt%). Additives, initiators, stabilizers and pigments are additional ingredients (< 1.0 wt%). While using the 3sCure mode of Bluephase Power-Cure (3.050mW/cm2), the material can be cured within 3 seconds. The material is available in syringes and cavifils.
Tetric® PowerFill composite material is available in Universal shades: IVA, IVB, IVW
Indications for Use:
Conventional application (Light intensity ≤2,000 mW/cm2):
-
Restorations in the posterior region (Class I and II, including the replacement of individual cusps)
-
Class V restorations (cervical caries, root erosion, wedge-shaped defects)
-
Reconstructive build-ups
-
Restoration of deciduous teeth
Light-curing using the 3sCure mode of Bluephase® PowerCure (Light Intensity 3,050 mW/cm2): - Restorations in the posterior region of permanent dentition (Class I and II, including the replacement of individual cusps) when light-cured from the occlusal aspect
AG
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Image /page/4/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" written below. Above the company name is a series of green and blue dots that form an arc. To the right of the logo is the number 2.
Comparison to Predicate: The primary predicate devices to which Tetric® PowerFill has been compared is Ivoclar Vivadent, AG Tetric EvoCeram Bulk Fill (K111958).
| Device | Ivoclar Vivadent AG: Tetric EvoCeramBulk Fill (K111958) | Ivoclar Vivadent: Tetric® PowerFill |
|---|---|---|
| Indications for Use | - Restoration of Deciduous teeth- Restorations in the posterior region(Class I and II)- Class V restorations (cervical caries,root erosion,wedge-shaped defects)- Extended fissure sealing in molars andpremolars | Conventional application (Lightintensity ≤ 2,000mW/cm2):- Restorations in the posterior region(Class I and II, including thereplacement of individual cusps)- Class V restorations (cervical caries,root erosion, wedge-shaped defects)- Reconstructive build-ups- Restoration of deciduous teethLight-curing using the 3sCure modeof Bluephase® PowerCure (LightIntensity 3,050 mW/cm2):- Restorations in the posterior region ofpermanent dentition (Class I and II,including the replacement of individualcusps) when light-cured from theocclusal aspect |
| Precaution Measures/Contraindications/Processing restrictions/Side effects | The placement of Tetric EvoCeramBulk Fill restorations iscontraindicated:- If a dry working field cannot beestablished, or the stipulated workingtechnique cannot be applied.- If a patient is known to be allergic toany of the ingredients of TetricEvoCeram Bulk Fill. | The placement of Tetric PowerFillrestorations iscontraindicated- If a dry working field cannot beestablished, or the stipulated workingprocedures cannot be applied.- If a patient is known to be allergic toany of the ingredients of TetricPowerFill |
| Side effectsIn individual cases, components ofTetric EvoCeram Bulk Fill may lead tosensitization. Tetric EvoCeram Bulk Fillshould not be used in such cases. Toavoid possible irritation of the pulp,areas close to the pulp should beprotected with a suitable pulp/dentinprotector (selectively apply a calciumhydroxide-based preparation in areasclose to the pulp and cover it with asuitable cavity liner). | Side effectsIn individual cases, components ofTetric PowerFill may lead tosensitization. Tetric PowerFill shouldnot be used in such cases. To avoidpossible irritation of the pulp, areasclose to the pulp should be protectedwith a suitable pulp/dentin protector(selectively apply a calciumhydroxide-based preparation in areasclose to the pulp and cover withsuitable cavity liner). | |
| WarningAvoid contact of unpolymerized TetricEvoCeram Bulk Fill with skin, mucousmembrane and eyes. UnpolymerizedTetric EvoCeram Bulk Fill may have aslight irritating effect and may lead to asensitization against methacrylates.Commercial medical gloves do not | WarningUnpolymerized Tetric PowerFill shouldnot come in contact with skin, mucousmembrane and eyes. UnpolymerizedTetric PowerFill may have a slightirritating effect and may lead to asensitization against methacrylates. | |
| provide protection against thesensitizing effect of methacrylates. | passion vision innovationCommercial medical gloves do notprovide protection against thesensitizing effect of methacrylates. | |
| Safety notes- Do not place light in direct contactwith unprotected gingiva, mucousmembrane or skin.- The 3sCure curing mode must not beused in case of caries profunda andvery deep cavities. | ||
| Summary ofIndications, PrecautionMeasures/Contraindications/Processing restrictions/Side effects | The new device Tetric PowerFill lacks the indication "Extended fissure sealing inmolars and premolars" in contrast to the predicate device and includes theindication "reconstructive build-ups". Extended fissure sealing is a feature thathas established itself for flowable composites and is therefore not intended forTetric PowerFill. All composites that can be used for direct occlusion fillings canalso be uses as reconstructive buildup materials as they have the physicalcharacteristics therefore.According to this the indication has been added to the new device TetricPowerFill.The contraindications are the same for both devices.Side effects and warnings are the same. The safety notes are an addition for thenew device because of the curing time of 3 seconds with a polymerization lightwith a light intensity of 3,050 mW/cm2. | |
| Technology | Tetric EvoCeram Bulk Fill is a light-curing, radiopaque nano-hybridcomposite for direct restorations inposterior teeth. Tetric EvoCeram BulkFill cures with light in the wavelengthrange of 400-500 nm and can beapplied in layers of up to 4 mm. | Tetric PowerFill is a light-curingradiopaque composite for the directrestorative treatment in posterior teeth.Tetric PowerFill cures with light in thewavelength range of 400-500 nm andcan be applied in layers of up to 4mm.While using the 3sCure mode ofBluephase Power- Cure(3,050mW/cm2), the material can becured within 3 seconds. |
| Summary of Technology | The working principle for both devices is substantially equivalent: both productsare light-curing resin-based dental restorative materials. Tetric PowerFill can becured with a dental curing light with a light intensity ≤ 2,000 mW/cm2 like itspredicate.The innovation of the new device Tetric PowerFill is that the device can be curedwithin 3 seconds using a curing light with a light intensity of 3,050 mW/cm2 forclass I and II restorations in the posterior region. | |
| Delivery forms/dosage | Syringes and cavifils | Syringes and cavifils |
| Summary of Deliveryforms/dosage | No difference. | |
| passion vision innovation | ||
| Storage Conditions | 48 months at 2-28 °C / 36-82 °F | 48 months at 2-28 °C / 36-82 °F |
| Summary of Storage Conditions | No difference. | |
| Principles of Operation | Step-by-step: | Step-by-step: |
| - Shade determination - Isolation - Cavity preparation - Pulp protection /Base - Apply matrix /interdental wedge - Conditioning / Application of the bonding agent - Application of Tetric Evoceram Bulk Fill - Finishing / Checking the occlusion / Polishing | - Shade determination - Isolation - Cavity preparation - Pulp protection/Base (3sCure mode is mentioned) - Apply matrix / interdental wedge - Conditioning/Application of the bonding agent - Application of Tetric PowerFill - Finishing /Checking the occlusion / Polishing | |
| Summary Principles of operation | The slight differences in the application are explained by the 3sCure mode of a curing light with a light Intensity of 3,050 mW/cm2.The principles of operation for the predicate and the new device are substantially equivalent. | |
| Finished Device Specification | Applicable standard: ISO 4049:2009- Dentistry - Polymer-based restorative materialsApplicable FDA Guidance: No information | Applicable standard: ISO 4049:2009- Dentistry- Polymer-based restorative materialsDental Composite Resin Devices – Premarket Notification [510(k)] Submission |
| Sterilization | Not applicable. No sterilization recommendation. | Not applicable. No sterilization recommendation. |
| Single use | Consumable material | Consumable material |
| Summary of Finished Device Specification | Tetric® PowerFill fulfils the relevant standard and follows the relevant Guidance. | |
| Summary of Performance Specification | The performance of the new device Tetric PowerFill is substantially equivalent to the predicate device. |
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Image /page/5/Picture/1 description: The image shows the Ivoclar Vivadent logo, which features the company name in blue with the tagline "passion vision innovation" underneath. Above the company name, there is a curved line of colored dots in green and blue. To the right of the logo, there is a number 3.
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Image /page/6/Picture/1 description: The image shows the Ivoclar Vivadent logo. The logo is blue and green, and it says "Ivoclar Vivadent" in a stylized font. Below the name is the text "passion vision innovation". To the right of the logo is the number 4.
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Image /page/7/Picture/1 description: The image shows the logo for Ivoclar Vivadent, a dental company. The logo features the company name in a stylized font, with the words "passion vision innovation" underneath. Above the company name is an arc of green and blue squares. To the right of the logo is the number 5.
Substantial equivalence to the predicate:
Both devices, the predicate Tetric EvoCeram Bulk Fill and the new device Tetric PowerFill are light-curing resin-based dental restorative composite devices. The physical properties are the same for both devices, the composition has been slightly changed for the new device.
Differences:
The slight differences in the application are explained by the 3sCure mode of a curing light with a light Intensity of 3,050 mW/cm2.
The principles of operation for the predicate and the new device are substantially equivalent.
Non-clinical performance testing:
Bench testing was performed to test the physical properties included in the Finished Device Specification for the subject device including: flexural strength, curing depth, sensitivity to light, wavelength for curing, water sorption and water solubility and radiopacity according to ISO 4049:2009. The subject device was tested in direct comparison to the predicate device and the results of the bench testing show the products to be substantially equivalent.
Biocompatibility:
The subject device was also evaluated for Biocompatibility according to ISO 10993-1:2009, ISO 7405:2008 and ISO 14971:2012. The following testing was conducted on the subject device: Cytotoxicity according to EN ISO 7405:2008 + A1:2013: ISO 10993-5:2009 and Genotoxicity according to EN ISO10993-3:2014 and the device was found to be non-cytotoxic and nongenotoxic. In addition to testing, additional criteria for biocompatibility including irritation, delayedtype hypersensitivity/Sensitization, systemic toxicity, implantation, and pulp and dentine usage were also evaluated based on a review of the literature and the evaluation concluded the benefits provided by the subject device will exceed any potential biocompatibility risks. This supports a finding of substantial equivalence due to the biocompatibility of the predicate device.
The Subject device was not tested or evaluated for pulp capping, endodontic usage, biodegradation, EMC, Software, animal and sterility validation as they are not applicable.
The results of the Biocompatibility Assessment for Tetric PowerFill is substantially equivalent to the results of the Biocompatibility Assessment for the predicate device Tetric EvoCeram Bulk Fill.
Conclusion:
The new device Tetric PowerFill is substantially equivalent to the predicate device Tetric EvoCeram Bulk Fill.
§ 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.