(113 days)
The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
The Dentivera™ Milling Discs are cylindrical, puck-shaped discs made from Ultaire™ AKP, an arylketone thermoplastic polymer resin with zinc oxide (ZnO) as an additive stabilizer. The milling discs are machined into partial or full removable denture frames using available dental CAD/CAM systems. The nominal dimensions are 98 mm in diameter and 28 mm thick.
The provided text describes a 510(k) premarket notification for a medical device called the Dentivera™ Milling Disc. It outlines the device's characteristics and compares it to a predicate device, Paladon 65, to establish substantial equivalence.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are primarily based on meeting or exceeding the minimum requirements of the ISO 20795-1 standard for Dentistry - Base polymers Part 1: Denture base polymers, specifically for mechanical properties. The device also underwent biocompatibility testing according to various ISO 10993 standards and USP <151>.
| Acceptance Criterion (Standard & Requirement) | Reported Device Performance (Dentivera™ Milling Disc) |
|---|---|
| Mechanical Properties (ISO 20795-1) | |
| Flexural Strength > 65 MPa | Pass |
| Flexural Modulus > 2000 MPa | Pass |
| Water Sorption ≤ 32 ug/mm³ | Pass |
| Water Solubility ≤ 1.6 ug/mm³ | Pass |
| Biocompatibility | |
| Cytotoxicity (ISO 10993-5) | Non-cytotoxic |
| Sensitization (ISO 10993-10) | Non-sensitizing |
| Intracutaneous Reactivity (ISO 10993-10) | Non-irritating |
| Systemic Toxicity Acute (ISO 10993-11) | Non-toxic |
| 13 Week Subchronic Systemic Toxicity (ISO 10993-6) | Non-toxic |
| Intramuscular Implantation Study - 4 Week (ISO 10993-6) | Non-irritating |
| Bacterial Reverse Mutation Assay (ISO 10993-3) | Non-mutagenic |
| Genotoxicity: Mouse Peripheral Blood Micronucleus Study (ISO 10993-3) | Non-genotoxic |
| Genotoxicity: Mouse Lymphoma Assay (ISO 10993-3) | Non-genotoxic |
| Pyrogen Test (USP <151>) | Non-pyrogenic |
| Chemical Characterization (ISO 10993-18) | Pass |
| Biological Risk Assessment (ISO 10993-1, ISO 14071) | Pass |
2. Sample Size Used for the Test Set and Data Provenance:
The document mentions "Side-by-side testing of the Dentivera™ Milling Disc resin and the Paladon 65 resins showed that both materials are compliant". However, the specific sample sizes for the mechanical property tests (Flexural Strength, Flexural Modulus, Water Sorption, Water Solubility) are not explicitly stated in the provided text. The data provenance is implied to be from laboratory testing as part of the submission, but no country of origin is specified. The studies are prospective in the sense that they were conducted specifically for this submission to demonstrate equivalence.
For the biocompatibility tests, the sample sizes are not explicitly stated either, which is common for summaries of these types of standardized tests.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
This document is for a material (denture base resin) and not an AI-powered diagnostic device. Therefore, the concept of "experts establishing ground truth for a test set" in the context of clinical interpretation (e.g., radiologists, pathologists) does not apply here. The "ground truth" for the material performance is established by compliance with internationally recognized standards (ISO, USP) through laboratory testing by qualified personnel using validated methods.
4. Adjudication Method for the Test Set:
Not applicable in this context. Adjudication methods (like 2+1, 3+1) are used in studies involving human interpretation of data where there might be disagreements, often for AI diagnostic devices. For material testing against defined standards, the outcome is typically a pass/fail based on pre-defined thresholds.
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 the device is a material (denture base resin) and not an AI-powered diagnostic tool requiring human interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
This information is not applicable as the device is a material and does not involve an algorithm or AI.
7. The Type of Ground Truth Used:
The ground truth for the device's performance is established by conformance to established international standards (ISO 20795-1 for mechanical properties, ISO 10993 series for biocompatibility, and USP <151> for pyrogenicity). These standards define the acceptable range of physical, chemical, and biological properties for these types of materials.
8. The Sample Size for the Training Set:
This information is not applicable. The Dentivera™ Milling Disc is a physical material, not an AI model that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
This information is not applicable. As stated above, the device is not an AI model.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 15, 2016
Dental Solutions, LLC % Brian Edwards Principal Medical Research Manager, Regulatory Namsa 4050 Olson Memorial Highway Golden Valley, Minnesota 55442
Re: K160498
Trade/Device Name: Dentivera Milling Disc Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI Dated: February 22, 2016 Received: May 5, 2016
Dear Brian Edwards:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Susan Runner, DDS, MA
Erin I. Keith, M.S. 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) K160498
Device Name
Dentivera™ Milling Disc
Indications for Use (Describe)
The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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1.0 510(k) Summary - K160498
1.1 Submission Sponsor
Kendra Shoulders Director of Global Regulatory Affairs Dental Solutions, LLC P.O. Box 270725 7701 Golden Valley Rd. Golden Valley, MN 55427 Phone: +1-770-772-8649 kmspanda@comcast.net
1.2 Submission Correspondent
Brian J. Edwards Principal Medical Research Manager, Regulatory NAMSA 4050 Olson Memorial Highway Suite 450 Minneapolis, MN 55422 Phone: +1-763-390-8409 Fax: +1-763-287-3836 bedwards@namsa.com
1.3 Date Prepared
June 8, 2016
1.4 Device Identification
| Trade/Proprietary Name: | Dentivera™ Milling Disc |
|---|---|
| Common/Usual Name: | Denture Base Resin |
| Classification Name: | Denture Relining, Repairing, and Rebasing Resin |
| Classification Regulation: | 21 CFR Part 872.3760 |
| Product Code: | EBI |
| Device Class: | II |
| Classification Panel: | Dental Devices |
| Model Numbers: | TBD |
1.5 Predicate Devices
The predicate device for the Dentivera™ Milling Disc is the Paladon 65 denture relining, repairing, and rebasing resin cleared on June 22, 1990 under 510(k) Number K901789.
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Both resin products are indicated for the manufacture of full and partial removable dentures and implant overdentures.
1.6 Device Description
The Dentivera™ Milling Discs are cylindrical, puck-shaped discs made from Ultaire™ AKP, an arylketone thermoplastic polymer resin with zinc oxide (ZnO) as an additive stabilizer.
Image /page/4/Picture/5 description: The image shows a circular object against a black background. The object appears to be a light beige or off-white color. It has a slightly raised edge, giving it a layered appearance.
Dentivera™ Milling Disc
The milling discs are machined into partial or full removable denture frames using available dental CAD/CAM systems. The nominal dimensions are 98 mm in diameter and 28 mm thick. This is the size that would fit most of the commercial dental milling machines currently used in dental laboratories.
1.7 Indication for Use
The Dentivera™ Milling Disc is a thermoplastic denture base resin designed for the manufacture of full and partial removable dentures and overdentures.
1.8 Contraindications
The Dentivera™ Milling Disc is not to be used in full removable dentures or permanent (i.e., cemented or implant retained) crowns, caps, bridges or superstructures.
1.9 Comparison to Predicates
The Dentivera™ Milling Disc resin is substantially equivalent to the Paladon 65 denture base resin in its performance and strength for the use in the manufacture of full and partial removable dentures and overdentures. The Paladon 65 denture based resin was cleared under 510(k) Number K901789. Both products are denture base materials used in the manufacture of full and partial removable dentures.
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When the Dentivera™ Milling Disc and the Paladon 65 are formed into the final denture base and frame products, both materials are used in identical ways and are both compliant with ISO 20795-1 for the strength and durability of denture base materials.
| Predicate Device(Predicate Device) | Dental SolutionsMilling Disc(Subject Device) | Discussion | |
|---|---|---|---|
| 510(k) Number | K901789 | K160498 | N/A |
| Manufacturer | Heraeus Kulzer, LLC300 Heraeus WaySouth Bend, Indiana46614 | Dental Solutions, LLC.P.O. Box 2707257701 Golden Valley Rd.Golden Valley, MN55427 | N/A |
| Classification | II | II | Same |
| Product Code | EBI | EBI | Same |
| Regulation | 21 CFR 872.3760 | 21 CFR 872.3760 | Same |
| Indications for Use | Paladon 65 is a denturebase resin designed forfixed and removabledentures: Full andpartial dentures. | The Dentivera™ MillingDisc is a thermoplasticdenture base resindesigned for themanufacture of full andpartial removabledentures andoverdentures. | SubstantiallyEquivalent |
| Main ChemicalComposition | Polymethyl acrylate;methyl methacrylate,dimethyl acrylate,impact modifier | Arylketonethermoplastic resin | SubstantiallyEquivalent |
| Shelf Life | 5 years | 10 years | SubstantiallyEquivalent |
| Denture FabricationMethod | Mixing and molding ofresin into physicalmold followed bycuring of resin | Pre-molding of resin intorigid disc followed byCAD/CAM milling ofdenture | SubstantiallyEquivalent |
| Flexural Strength > 65MPa(ISO 20795-1) | Pass | Pass | SubstantiallyEquivalent |
| Flexural Modulus >2000 MPa(ISO 20795-1) | Pass | Pass | SubstantiallyEquivalent |
| Water Sorption ≤ 32ug/mm3(ISO 20795-1) | Pass | Pass | SubstantiallyEquivalent |
| Water Solubility ≤ 1.6ug/mm3(ISO 20795-1) | Pass | Pass | SubstantiallyEquivalent |
Table 3: Dental Solutions Dentivera™ Milling Disc Substantial Equivalence Table
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As outlined above, the Dental Solutions Denitvera™ Milling Disc resin and the Paladon 65 resin are substantially equivalent is use and both materials physical properties exceed the minimum requirements of ISO 20795-1 for Denture base polymers and resins. The use of the Dentivera™ Milling Disc does not result in any additional risks over and above that of the Paladon 65.
1.10Performance Testing
Side-by-side testing of the Dentivera™ Milling Disc resin and the Paladon 65 resins showed that both materials are compliant with the ISO 20795-1 : Dentistry -Base polymers Part 1: Denture base polymers standard relating to mechanical properties of denture base materials. These results are summarized in the Substantial Equivalence table above.
In addition, biocompatibility testing was performed on the Dentivera™ Milling Disc resin in accordance with ISO 10993-1.
| Test | StandardApplied | Relevant Results |
|---|---|---|
| CytotoxicityMEM Elution Method | ISO 10993-5 | Non-cytotoxic |
| SensitizationGuinea Pig Maximization | ISO 10993-10 | Non-sensitizing |
| Intracutaneous Reactivity | ISO 10993-10 | Non-irritating |
| Systemic Toxicity AcuteSystemic Injection | ISO 10993-11 | Non-toxic |
| 13 Week SubchronicSystemic Toxicity in Rats,Subcutaneous Implantation | ISO 10993-6 | Non-toxic |
| Intramuscular ImplantationStudy - 4 Week | ISO 10993-6 | Non-irritating |
| Bacterial Reverse MutationAssay | ISO 10993-3 | Non-mutagenic |
| Genotoxicity: MousePeripheral BloodMicronucleus Study | ISO 10993-3 | Non-genotoxic |
| Genotoxicity: MouseLymphoma Assay | ISO 10993-3 | Non-genotoxic |
| Pyrogen Test | USP <151> | Non-pyrogenic |
Table 4: Biocompatibility Testing Summary of Dentivera™ Milling Disc Ultaire™ AKP resin
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| Test | StandardApplied | Relevant Results |
|---|---|---|
| Chemical Characterizationof PXM-15263 Resin | ISO 10993-18 | Pass |
| Chemical Characterizationof PXM-15263 Discs | ISO 10993-18 | Pass |
| Biological Risk AssessmentDental Milling Disc | ISO 10993-1ISO 14071 | Pass |
1.11 Conclusion
Dental Solutions LLC considers the Dentivera™ Milling Disc denture base resin to be substantially equivalent to the Paladon 65 denture base resin in that its use and performance as a denture base resin is equivalent to the predicate in terms of chemical characterization, biocompatibility and ISO based performance testing. . This conclusion is based upon the devices' similarities in intended use, design, and mechanical properties.
§ 872.3760 Denture relining, repairing, or rebasing resin.
(a)
Identification. A denture relining, repairing, or rebasing resin is a device composed of materials such as methylmethacrylate, intended to reline a denture surface that contacts tissue, to repair a fractured denture, or to form a new denture base. This device is not available for over-the-counter (OTC) use.(b)
Classification. Class II.