(93 days)
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- Splinting
els extra low shrinkage® flow is indicated for:
- Restorations with minimally invasive preparation technique
- Restorations of small cavities and extended fissure sealing
- Alternate restorations for undercut cavities
- Restorations of class III V including wedged shaped defects and cervical caries
- Repair of fillings, veneers and methacrylate-based temporary restorations
- First layer of fillings for Class I and II
- Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth.
els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
This document is a 510(k) summary for the "els extra low shrinkage® composite" and "els extra low shrinkage® flow" dental restorative materials. It does not describe a study involving an AI/software device that requires intricate details on acceptance criteria and performance evaluation against a defined ground truth. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance (bench testing) and material comparison.
Therefore, many of the requested categories for AI/software studies are not applicable to the information provided in this document.
However, I can extract the information that is relevant to the non-clinical performance and acceptance criteria for these dental materials:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for "els extra low shrinkage® composite" and "els extra low shrinkage® flow" are based on meeting the requirements of the ISO standard ISO 4049:2009 - Dentistry - Polymer-based restorative materials. The tables below show a comparison of the device's physical properties against predicate devices, indicating that the device performance meets these standards.
els extra low shrinkage® composite (els composite) Performance vs. Predicate Devices
| Attribute | Acceptance Criteria (Implied by ISO 4049 & Predicate Range) | els composite Reported Performance | Denomination of acceptance range compliance (Pass/Fail) |
|---|---|---|---|
| Compressive Strength | Met by ISO 4049 (Predicate: 187.4-285 MPa) | Avg. = 289.8 MPa | Pass (Higher strength does not affect substantial equivalence) |
| Surface Hardness | Met by ISO 4049 (Predicate: 43.86 KHN - Unknown) | Avg. = 76 Vicker's Hardness | Pass (Typical standard for composites) |
| Flexural Strength | Met by ISO 4049 (Predicate: 125.4-135.74 MPa) | Avg. = 116.3 MPa | Pass (Meets same ISO 4049 performance requirements) |
| Water Sorption | Met by ISO 4049 (Predicate: 18.2-18.48 µg/mm3) | Avg. = 14.7 µg/mm3 | Pass (Meets same ISO 4049 performance requirements) |
| Solubility | Met by ISO 4049 (Predicate: 0.3-0.82 µg/mm3) | Avg. = 0.8 µg/mm3 | Pass (Meets same ISO 4049 performance requirements) |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | Pass |
| Radiopacity | Met by ISO 4049 (Predicate: 3.2 mm Al) | Avg. = 2.8 mm Al | Pass (Meets same ISO 4049 performance requirements) |
els extra low shrinkage® flow (els flow) Performance vs. Predicate Devices
| Attribute | Acceptance Criteria (Implied by ISO 4049 & Predicate Range) | els flow Reported Performance | Denomination of acceptance range compliance (Pass/Fail) |
|---|---|---|---|
| Compressive Strength | Met by ISO 4049 (Predicate: 332-415 MPa) | Avg. = 225.1 MPa | Pass (Suitable for small cavities, not requiring higher strength) |
| Surface Hardness | Met by ISO 4049 (Predicate: Unknown) | Avg. = 55 Vicker's Hardness | Pass (No available data to compare with) |
| Flexural Strength | Met by ISO 4049 (Predicate: 96-117 MPa) | Avg. = 116.5 MPa | Pass (Meets same ISO 4049 performance requirements) |
| Water Sorption | Met by ISO 4049 (Predicate: ≤40 - 23 µg/mm³) | Avg. = 19.0 µg/mm³ | Pass (Meets same ISO 4049 performance requirements) |
| Solubility | Met by ISO 4049 (Predicate: ≤ 7.5 - 2.0 µg/mm³) | Avg. = 1.5 µg/mm³ | Pass (Meets same ISO 4049 performance requirements) |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | Pass |
| Radiopacity | Met by ISO 4049 (Predicate: 3.1 - 2.2 mm Al) | Avg. = 1.3 mm Al | Pass (Meets same ISO 4049 performance requirements) |
The following points are not applicable as this submission is for dental restorative materials, not an AI/software device. The document explicitly states: "No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow."
- Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable (no human clinical test set).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable (ground truth not established by experts as there are no human clinical outcomes).
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable (ground truth is derived from compliance with ISO standards for physical and chemical properties).
- The sample size for the training set: Not applicable as there is no training set for an AI/software device. The product underwent non-clinical bench testing.
- How the ground truth for the training set was established: Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & 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.
June 27, 2024
Saremco Dental AG % Nevine Erian Regulatory Consultant BOC Consulting, LLC 24341 Barbados Dr. Dana Point, California 92629-92629
Re: K240823
Trade/Device Name: els extra low shrinkage® composite & els extra low shrinkage® flow Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: March 21, 2024 Received: March 26, 2024
Dear Nevine Erian:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"
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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Bobak Shirmohammadi -S
For Michael E. Adjodha, M.ChE., RAC, COIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia,
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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
Submission Number (if known)
Device Name
els extra low shrinkage® composite & els extra low shrinkage® flow
Indications for Use (Describe)
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- D Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- [ Indirect anterior and posterior restorations including inlays, onlays and veneers
- [ Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- 0 Splinting
els extra low shrinkage® flow is indicated for:
- [ Restorations with minimally invasive preparation technique
- [ Restorations of small cavities and extended fissure sealing
- [ Alternate restorations for undercut cavities
- [ Restorations of class III V including wedged shaped defects and cervical caries
- □ Repair of fillings, veneers and methacrylate-based temporary restorations
- □ First layer of fillings for Class I and II
- I Interlocking of loosened teeth
- [ Adhesive attachment of indirect composite and ceramic restorations
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
ver-The-Counter Use (21 CFR 801 Subpart C)
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K240823 – 510(k) Summary
| Submitter | Saremco Dental AGGewerbestrasse 4CH-9445 Rebstein, SwitzerlandEstablishment Reg. No. 3008582054 |
|---|---|
| Contact | Dr. Christoph EversHead of R&DPhone +41 71 775 80 90Fax +41 71 775 80 99E-Mail christoph.evers@saremco.ch |
| Official Correspondent | Nevine Erian |
|---|---|
| Regulatory Consultant | |
| BQC Consulting, LLC | |
| 24341 Barbados Dr. | |
| Dana Point, CA 92629 | |
| Phone (949) 370-7155 | |
| Fax (949) 240-8829 | |
| E-mail nevine@bqcconsulting.com |
Date Prepared June 24, 2024
| Trade/Device Names | els extra low shrinkage® compositeels extra low shrinkage® flow |
|---|---|
| Common Name | Tooth Shade Resin Material |
| Classification Name &Regulation Number | Tooth Shade Resin Material - 21 CFR 872.3690 |
| Product Code | EBF |
Predicate Devices
DENU Composite Resin (HDI, Inc.) – K213339 – Primary Predicate
Brilliant EverGlow Flow (Coltene/Whaledent AG) – K190597 – Reference Device
Brilliant Componeer (Coltene/Whaledent AG) – K191385 – Reference Device
Venus Diamond flow (Heraeus Kulzer GmbH) – K091635 – Reference Device
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Device Description
els extra low shrinkage® composite is classified as a Type 1, Class 2, Group 1 & 2 Polymerbased restorative material according to ISO 4049:2009 - Dentistry - Polymer-based restorative materials.
els extra low shrinkage® flow is classified as Type 2, Class 2, Group 1 Polymer-based restorative material according to ISO 4049:2009 – Dentistry – Polymer-based restorative materials.
Statement of Intended Use
els extra low shrinkage® composite & els extra low shrinkage® flow are light-cured methacrylate-based resins that are intended to fill and restore small to large defects or carious lesions in teeth. The patient population includes with permanent dentition needing restoration.
Statement of Indication for Use
els extra low shrinkage® composite & els extra low shrinkage® flow are restorative materials intended for the reconstruction or correction of natural dentition.
els extra low shrinkage® composite is indicated for:
- Restoration of class I, II, III, IV and V cavities on anterior and posterior teeth
- . Indirect anterior and posterior restorations including inlays, onlays and veneers
- Aesthetic corrections of interdental spaces, enamel hypoplasia, discolorations
- 트 Splinting
els extra low shrinkage® flow is indicated for:
- 트 Restorations with minimally invasive preparation technique
- 트 Restorations of small cavities and extended fissure sealing
- 트 Alternate restorations for undercut cavities
- . Restorations of class III - V including wedged shaped defects and cervical caries
- 트 Repair of fillings, veneers and methacrylate-based temporary restorations
- 트 First layer of fillings for Class I and II
- 트 Interlocking of loosened teeth
- Adhesive attachment of indirect composite and ceramic restorations
Material Composition
els extra low shrinkage® composite & els extra low shrinkage® flow are composed of methacrylate-based resins, dental glass-filler, photo initiators and pigments.
Technological Characteristics
els extra low shrinkage® composite & els extra low shrinkage® flow are light cured radiopaque microhybrid composites with extremely low shrinkage stress.
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Non-Clinical Performance Testing
els extra low shrinkage® composite & els extra low shrinkage® flow were tested and met the applicable requirements of the following ISO standard ISO 4049:2009 - Dentistry -Polymer-based restorative materials
Bench test results allowed us to conclude that els extra low shrinkage® composite & els extra low shrinkage® flow meet their intended uses.
Biocompatibility
els extra low shrinkage® composite & els extra low shrinkage® flow meet the biocompatibility requirements of the following standards:
- l ISO 10993-1:2018 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within a Risk Management Process
- -ISO 7405:2018 Dentistry – Evaluation of Biocompatibility of Medical Devices Used in Dentistry
Clinical Performance Data
The performance of methacrylate-based polymer resins in the clinical environment has been well established. No human clinical testing was performed to support the substantial equivalence of els extra low shrinkage® composite & els extra low shrinkage® flow.
Substantial Equivalence
The technical characteristics of els extra low shrinkage® composite & els extra low shrinkage® flow are substantially equivalent to the predicate devices.
Material
els extra low shrinkage® composite & els extra low shrinkage® flow are resin-based materials as the predicate devices.
Physical Properties
els extra low shrinkage® composite & els extra low shrinkage® flow have similar physical properties as the predicate devices.
Comparison of saremco els extra low shrinkage® composite (els composite for short) to Predicate Devices
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| Attribute | els composite | DENU CompositeResin | BrilliantComponeer | Rationale for Difference |
|---|---|---|---|---|
| Indications | els extra lowshrinkage®composite is arestorativematerial intendedfor thereconstruction orcorrection ofnatural dentition.- Restoration ofclass I, II, III, IVand V cavities onanterior andposterior teeth- Indirect anteriorand posteriorrestorationsincluding inlays,onlays andveneers- Aestheticcorrections ofinterdentalspaces, enamelhypoplasia,discolorations- Splinting | DENU CompositeResin is indicatedfor use in:- Direct anteriorand posteriorrestorations- Core buildup- Splinting- Indirect anteriorand posteriorrestorationsincluding inlays,onlays andveneers | Clinical indications- Restoration ofcaries defects- Reconstructionof lost toothsubstance due toattrition,abrasion, erosion- Restoration oftooth fractures- Correction ofanatomicalmalformationCosmeticindications- Optimisation ofold compositerestorations- Extendingincisors- Correction ofmalpositionedteeth- Cosmeticcorrections fortoothdiscolouration orincorrect shading- Closure ofdiastema | The verbiage describing the indicationsfor Use of els composite and thepredicate, DENU Composite resin, isslightly different. The wording used bythe primary predicate (namely: "Directanterior and posterior restorations")describes a much broader field incomparison to "Restoration of class I, II,III, IV and V cavities on anterior andposterior teeth". The indications"Indirect anterior and posteriorrestorations including inlays, onlays andveneers" and "Splinting" are equal onboth sides.The formulations describing theindications for the use of els compositeand the predicate "Brilliant Componeer"are different. The wording of thepredicate (namely: "- Restoration of caries defects- Reconstruction of lost tooth substancedue to attrition, abrasion, erosion- Restoration of tooth fractures- Correction of anatomicalmalformation") also describes a muchbroader range compared to theindications of the els composite"Restoration of class I, II, III, IV and Vcavities on anterior and posteriorteeth", "Indirect anterior and posteriorrestorations including inlays, onlays andveneers" and "Splinting".The other indications of the predicatedevice "Brilliant Componeer" incomparison to the proposed elscomposite hybrid list the estheticcorrections: (Cosmetic indications- Optimization of old compositerestorations- Extending incisors- Correction of mal-positioned teeth- Cosmetic corrections for toothdiscoloration or incorrect shading- Closure of diastema"),whereby a much broader range ofesthetic corrections is also mentioned |
| Attribute | els composite | DENU CompositeResin | BrilliantComponeer | Rationale forDifference |
| Physical Properties | ||||
| Physical State | Uncured resinpaste | Uncured resinpaste | Polymerizedprefabricatedhybrid compositeenamel shell | After light curing,els composite andDenu CompositeResin perform thesame as BrilliantComponeer |
| Material Color | Various shades | Various shades | Various shades | Shade differencesdo not affect deviceperformance |
| Packaging | Prefilled syringes& tips | Prefilled syringes | Preformed shellsin box | Packagingdifferences do notimpact cureddevice performance |
| CompressiveStrength | Avg. = 289.8 MPa | 187.4 MPa | 285 MPa | Though differentcompressivestrength values, insubject andpredicate devices,higher strength ofels composite doesnot affectsubstantialequivalence. |
| Surface Hardness | Avg. = 76Vicker's Hardness | 43.86 KHN | Unknown | Surface hardnessvalues are notcomparable due tolack of availabledata. Vicker'sHardness is atypical standard forcomposites. |
| Performance Testing | ISO 4049 | ISO 4049 | ISO 4049 | |
| Flexural Strength | Avg. = 116.3 MPa | 135.74 MPa | 125.4 MPa | Though differentvalues, subject andpredicate devicesmeet same ISO4049 performancerequirements |
| Attribute | els composite | DENU CompositeResin | BrilliantComponeer | Rationale forDifference |
| Water Sorption | Avg. =14.7 µg/mm3 | 18.48 µg/mm3 | 18.2 µg/mm3 | Though differentvalues, subject andpredicate devicesmeet same ISO4049 performancerequirements |
| Solubility | Avg. = 0.8 µg/mm3 | 0.82 µg/mm3 | 0.3 µg/mm3 | Though differentvalues, subject andpredicate devicesmeet same ISO4049 performancerequirements |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | ≥ 1.5 mm | - |
| Radiopacity | Avg. = 2.8 mm Al | 3.2 mm Al | 3.2 mm Al | Though differentvalues, subject andpredicate devicesmeet same ISO4049 performancerequirements |
| MaterialComparison | ||||
| ChemicalCharacterization | Methacrylate-basedresins, dental glass-filler, photoinitiatorsand pigments. | Methacrylate-based resins,dental glass-filler,photo initiatorsand pigments. | Methacrylate-based resins,dental glass-filler,photo initiatorsand pigments. | |
| Technical Attributes | ||||
| Product Code(s) | EBF | EBF, EBC & EJK | EBF | Subject device hasless indicationsthan predicates |
| Fabrication Method | Light Cured | Light Cured | Light Cured | After light curing,els composite andDenu CompositeResin perform thesame as BrilliantComponeer |
| Curing Wavelength | 400 - 500 nm | 400 - 500 nm | Unknown | - |
| PolymerizationMethod | UV Curing Light | UV Curing Light | UV Curing Light | - |
| Sterile | No | No | No | - |
| Rx or OTC | Rx | Rx | Rx | - |
| Attribute | Els flow | BRILLIANTEverGlow Flow | Venus Diamond flow | Rationale for Differnce |
| Indi-cation | els extra lowshrinkage® flow isa restorativematerial intended | BRILLIANT EverGlowFlow Universal andTranslucent shadesare suitable for:- Direct class Vfillings (cervicalcaries, root erosion,wedge-shapeddefects)- Fillings in theanterior toothregion (Class III andIV)- Small fillings of allcavity classes (notocclusion-bearing)- Blocking out ofundercuts- Adhesive luting ofindirect compositeand ceramicrestorations in as faras accuracy of fitand lightpermeability aregiven- Repairs of directand indirectcompositerestorations- Preventive resinrestorations- Cavity liningBRILLIANT EverGlowFlow opaque shadeis also suitable for:- Aestheticcorrections (e.g.deviations inchroma)- Masking of darkareas | - Enlarged fissuresealing- Cavity lining - as thefirst layer forClass I and II cavities- Class V fillings- Minimally invasiveClass I and II fillings inareas not subjectedto masticatory forces- Minimally invasiveClass III fillings- Small repairs ofdirect and indirectrestorationscombined with asuitable bondingagent- Interlocking ofloosened teeth | The formulations describingthe indications for the use ofels-Flow and the predicate"Brilliant Everglow flow" arevery similar. Only theindication "blocking ofloosened teeth" is notmentioned. Although notexplicitly mentioned, allindications describe "fillingswith minimally invasivepreparation technique", whichalso covers this indication of elsflow.The formulations describingthe indications for the use ofels Flow and the "VenusDiamond flow" predicate arealso very similar. However, theindications "Replacementfillings in cavities withundercuts" and "Adhesivecementation of indirectcomposite or ceramicrestorations" are missing here,but these are covered by the"Brilliant Everglow flow"predicate. |
| Attribute | els flow | BRILLIANTEverGlow Flow | Venus Diamondflow | Rationale for Difference |
| PhysicalProperties | ||||
| Physical State | Uncured resin paste | Uncured resin paste | Uncured resin paste | - |
| Material Type | Polymer resincomposite | Polymer resincomposite | Polymer resincomposite | - |
| Material Color | Various shades | Various shades | Various shades | Shade differences do notaffect device performance |
| Packaging | Prefilled syringes | Prefilled syringes | Prefilled syringes | - |
| CompressiveStrength | Avg. = 225.1 MPa | 415 MPa | 332 MPa | Though differentcompressive strengthvalues, in subject andpredicate devices, els flowis only used for smallcavities, which do notrequire higher compressivestrength |
| SurfaceHardness | Avg. = 55Vicker's Hardness | Unknown | Unknown | No available data tocompare with |
| PerformanceTesting | ISO 4049 | ISO 4049 | ISO 4049 | - |
| FlexuralStrength | Avg. = 116.5 MPa | 96 MPa | 117 MPa | Though different values,subject and predicatedevices meet same ISO4049 performancerequirements |
| WaterSorption | Avg. = 19.0 µg/mm³ | 23 µg/mm³ | ≤40 µg/mm³ | Though different values,subject and predicatedevices meet same ISO4049 performancerequirements |
| Solubility | Avg. = 1.5 µg/mm³ | 2.0 µg/mm³ | ≤ 7.5 µg/mm³ | Though different values,subject and predicatedevices meet same ISO4049 performancerequirements |
| Depth of Cure | ≥ 1.5 mm | ≥ 1.5 mm | ≥ 1.5 mm | - |
| Radiopacity | Avg. = 1.3 mm Al | 2.2 mm Al | 3.1 mm Al | Though different values,subject and predicatedevices meet same ISO4049 performancerequirements |
| Attribute | els flow | BRILLIANTEverGlow Flow | Venus Diamondflow | Rationale for Difference |
| MaterialComparison | ||||
| ChemicalCharacterization | Methacrylate-basedresins, dental glass-filler, photoinitiatorsand pigments. | Methacrylate-basedresins, dental glass-filler, photoinitiatorsand pigments. | Methacrylate-basedresins, dental glass-filler, photoinitiatorsand pigments. | |
| TechnicalAttributes | ||||
| ProductCode(s) | EBF | EBF | EBF, EBC & LBH | Subject device has lessindications than VenusDiamond flow |
| FabricationMethod | Light Cured | Light Cured | Light Cured | |
| CuringWavelength | 400 - 500 nm | 430 - 490 nm | 450 - 480 nm | Subject device curingwavelength is comparableto predicates |
| PolymerizationMethod | UV Curing Light | UV Curing Light | UV Curing Light | |
| Sterile | No | No | No | |
| Rx or OTC | Rx | Rx | Rx |
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Comparison of saremco els extra low shrinkage® flow (els flow for short) to Predicate Devices
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Differences between els extra low shrinkage® composite & els extra low shrinkage® flow and Predicate Devices
The differences in the physical properties and chemical compositions between els extra low shrinkage® composite & els extra low shrinkage® flow and the predicate devices do not impact the substantial equivalence, as the finished clinical product is a custom-fitted biocompatible restoration regardless of the material variation.
Conclusion
Information provided in this application demonstrates that els extra low shrinkage® composite & els extra low shrinkage® flow are substantially equivalent to the predicate devices. els extra low shrinkage® composite & els extra low shrinkage® flow share the
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same indications for use, similar material composition, similar physical properties and technological characteristics as the predicate devices.
§ 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.