(268 days)
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization. Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and post-processing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing. The 3D printer is not included with the device.
The provided document describes a medical device, "Harvest Printable Resin," and its substantial equivalence to predicate devices based on technological characteristics and performance data, primarily through biocompatibility testing and ISO 20795-1 & -2 testing.
Here's an analysis of the acceptance criteria and the study proving the device meets them, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard Reference) | Reported Device Performance (Harvest Printable Resin) | Predicate Device 1 (NextDent Denture/E-Denture) Performance | Predicate Device 2 (E-Guard) Performance | Comparison to Criteria |
|---|---|---|---|---|
| Ultimate Flexural Strength (ISO 20795-1) | ≥ 65 MPa (reported: 81.6 MPa) | ≥ 65 MPa (reported: 84 MPa) | N/A | Passed |
| Ultimate Flexural Strength (ISO 20795-2) | ≥ 50 MPa (reported: 81.6 MPa) | N/A | ≥ 50 MPa (reported: 79.4 - 85.1 MPa) | Passed |
| Flexural Modulus (ISO 20795-1) | ≥ 2,000 MPa (reported: 2,339 MPa) | ≥ 2,000 MPa (reported: 2,383 MPa) | N/A | Passed |
| Flexural Modulus (ISO 20795-2) | ≥ 1,500 MPa (reported: 2,339 MPa) | N/A | ≥ 1,500 MPa (reported: 2050-2130 MPa) | Passed |
| Water Sorption (ISO 20795-1) | ≤ 32 µg/mm³ (reported: 24.3 µg/mm³) | ≤ 32 µg/mm³ (reported: 28 µg/mm³) | N/A | Passed |
| Water Sorption (ISO 20795-2) | ≤ 32 µg/mm³ (reported: 24.3 µg/mm³) | N/A | ≤ 32 µg/mm³ (reported: 30-32 µg/mm³) | Passed |
| Water Solubility (ISO 20795-1) | ≤ 1.6 µg/mm³ (reported: 1.1 µg/mm³) | ≤ 1.6 µg/mm³ (reported: 0.1 µg/mm³) | N/A | Passed |
| Water Solubility (ISO 20795-2) | ≤ 5 µg/mm³ (reported: 1.1 µg/mm³) | N/A | ≤ 5 µg/mm³ (reported: 0.5 µg/mm³) | Passed |
| Residual Monomer | None (no MMA monomers used for production) | ≤ 0.1% (w/w) (for some MMA) / ≤ 2.2% (w/w) | Unknown | Improved |
| Biocompatibility | Adequate biocompatibility | N/A (implied by predicate status) | N/A (implied by predicate status) | Passed |
2. Sample size used for the test set and the data provenance
The document does not explicitly state the sample sizes used for the ISO 20795-1 & -2 tests or the biocompatibility tests. It also does not specify the provenance (e.g., country of origin, retrospective or prospective) of the data. These tests are typically conducted in a laboratory setting on standardized test specimens.
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 and not provided in the document. The "ground truth" for material property testing (like ISO 20795-1 & -2) and biocompatibility is established by adherence to recognized international standards and laboratory measurements, not by expert consensus on clinical cases. No human-in-the-loop performance is being evaluated here.
4. Adjudication method for the test set
Not applicable. As noted above, this is material property and biocompatibility testing, not a clinical assessment requiring adjudication of human expert opinions.
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
No MRMC comparative effectiveness study was done. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." This device is a material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, "standalone" performance was effectively done in the form of laboratory testing of the material properties described in section 1 and biocompatibility. The performance evaluation focuses solely on the inherent characteristics of the Harvest Printable Resin itself, without any human intervention in its measurement or any AI algorithms.
7. The type of ground truth used
The ground truth for the performance evaluation relies on:
- Established International Standards: ISO 20795-1:2013 and ISO 20795-2:2013 for physical/mechanical properties. These standards define the methodology and acceptance criteria.
- Recognized Biocompatibility Standards: ISO 7405:2018 and ISO 10993-1 as recognized by the FDA for biocompatibility. These standards outline tests to ensure the material is safe for biological contact.
8. The sample size for the training set
Not applicable. This device is a material, not an AI model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services. To the right of the symbol, there is a blue square with the letters "FDA" in white. Next to the blue square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
May 12, 2023
Harvest Dental Products, LLC Colleen Boswell Regulatory Affairs Consultant 905 Columbia Street Brea, California 92821
Re: K222489
Trade/Device Name: Harvest Printable Resin Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, ELM, MQC Dated: April 25, 2023 Received: April 25, 2023
Dear Colleen Boswell:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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,
Bobak Shirmohammadi -2
For Michael E. Adjodha, M. ChE., CQIA 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
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Indications for Use
Submission Number (if known)
Device Name
Harvest Printable Resin
Indications for Use (Describe)
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
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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Image /page/3/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features two green leaves above the text "HarvestDental" in gray. Below "HarvestDental" is the text "LABORATORY PRODUCTS" in a smaller, gray font.
510(k) Summary
-
- Submitter:
Harvest Dental Products, LLC 905 Columbia Street Brea, California 92821
- Submitter:
| Contact Person: | Colleen Boswell |
|---|---|
| Telephone Number: | (714) 674-7400 |
| Fax Number: | (714) 674-7402 |
Date Prepared: April 23, 2023
-
- Device:
| Name of Device: | Harvest Printable Resin |
|---|---|
| Common Name: | Denture relining, repairing, rebasing resin |
| Denture, plastic teeth | |
| Prescription mouthguard |
| Classification Name/ | Denture Relining, Repairing, or Rebasing Resin, per 21 |
|---|---|
| Device Classification/ | CFR 872.3760, II, EBI (Primary classification) |
| Device Class/ | Denture, Plastic, Teeth, per 21 CFR § 872.3590, II, ELM |
| Product Code: | Unclassified (Mouthguard), MQC |
-
- Predicate Device:
| Primary Predicate: | NextDent Denture/E-Denture , Vertex-Dental B.V., K162572, Product Code EBI |
|---|---|
| Secondary Predicate: | E-Guard , EnvisionTEC GmbH, K201173, Product Code MQC, EB |
4. Device Description
Harvest Printable Resin is a light-cured resin developed for additive manufacturing (3D printing) of individual full denture bases, artificial teeth, bite splints and guards and try-in devices, i.e., denture base and teeth. After being utilized in a 3D stereolithographic printer to generate a dental device based on a solid model, the device is placed in a UV light curing unit for final polymerization.
Fabrication using Harvest Printable Resin requires an appropriate computer-aided Design and Manufacturing (CAD/CAM) system, a digital light processing (DLP) printer, and postprocessing light curing equipment. It has been optimized for use with Asiga (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Pro95 S and Pro55 S) printers and, therefore, may only be used in conjunction with these printers and their associated software systems. It is also only to be used in conjunction with Asiqa (Max UV, Pro 4K65 and Pro 4K80) and Sprintray (Procure and Procure 2) curing units for post-processing.
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Image /page/4/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features the words "Harvest Dental" in a stacked format, with "Harvest" in gray and "Dental" in green. Above the text is a graphic of two green leaves, one larger than the other. Below the text, in smaller gray font, are the words "LABORATORY PRODUCTS".
The 3D printer is not included with the device.
5. Statement of Indications for Use:
Harvest Printable Resin is indicated for the fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints and guards and try-in devices, i.e., denture base and teeth. The material is an alternative to traditional heat-curable and auto-polymerizing resins and is intended for professional dental work only. This material is intended to be used by dental lab technicians and approved by licensed practitioners before being provided to the patient.
6. Summary of Technological Characteristics with the Predicate Device
The technological characteristics of the subject Harvest Printable Resin is similar to the predicate devices, NextDent Denture/E-Denture (K162572) and E-Guard (K201173). There are no substantial technical or functional differences between the Harvest Printable Resin and the predicate devices in terms of chemical composition, function and intended use. All are light-cured resins used in a 3D printer which prints the shape determined by a 3D stereolithographic drawing. See Table 1 below for technological characteristics and comparisons of the denture relining, rebasing resin, plastic denture teeth resin and prescription mouthguard and splints resin.
| Table 1: Comparison of Subject and Predicate Devices | ||||
|---|---|---|---|---|
| -- | -- | -- | -- | ------------------------------------------------------- |
| Element | Harvest Printable Resin(Proposed Device) | NextDent Denture/E-Denture(Primary Predicate) | E-Guard(Secondary Predicate) | Comparison |
|---|---|---|---|---|
| Manufacturer | Harvest Dental Products, LLC | Vertex-Dental B.V. | EnvisionTEC GmbH | N/A |
| 510(k) | K222489 | K162572 | K201173 | N/A |
| Target Users | Dental laboratories | Healthcarefacility/hospital, dental(technical) laboratory | Dental laboratoriesand dental practices | Same |
| Common Name | Printable Resin | Printable Resin | Printable Resin | Same |
| Device Description | Harvest Printable Resin islight-cured resin developedfor additive manufacturing(3D printing) of individual fulldenture bases, artificialteeth, bite splints and guardsand try-in devices, i.e.,denture base and teeth.After being utilized in a 3Dstereolithographic printer togenerate a dental devicebased on a solid model, thedevice is placed in a UV light | NextDent Denture/ E-Denture 3D-printingmaterial is a light-curedresin indicated for themanufacturing of denturebases. The material isused in a 3D printer,which prints the shapedetermined by a 3Dstereolithographicdrawing. After printing,the printed product isplaced in a UV-light | The E-Guard systemcombines a scannerwith design software,the light-cured resin, a3D printer and acuring unit. Thesecomponents are usedtogether during themanufacture of thedental appliancesplint/bite guard. Thelight-curing resin iscomposed of acrylate/ | Same. Theresins are usedin the 3Dprinting ofdental devicesincludingdenture bases,bite splits andguards.Note: Artificialteeth are 510(k)exempt and the |
| Element | Harvest Printable Resin(Proposed Device) | NextDent Denture/E-Denture(Primary Predicate) | E-Guard(Secondary Predicate) | Comparison |
| curing unit for finalpolymerization.Fabrication using Harvest Printable Resin requires anappropriate computer-aidedDesign and Manufacturing(CAD/CAM) system, a digitallight processing (DLP)printer, and post-processinglight curing equipment. Ithas been optimized for usewith Asiga (Max UV, Pro4K65 and Pro 4K80) andSprintray (Pro95 S and Pro55S) printers and, therefore,may only be used inconjunction with theseprinters and their associatedsoftware systems. It is alsoonly to be used inconjunction with Asiga (MaxUV, Pro 4K65 and Pro 4K80)and Sprintray (Procure andProcure 2) curing units forpost-processing.The 3D printer is notincluded with the device. | curing box for finalpolymerization.3D printer is not includedwith the device. | methacrylate,methacrylatedoligomers andmonomers, photoinitiators,colorants/dyes andabsorbers. It is usedby dental laboratoriesand dental practicesto make customizedbite splints, using the3D-printer. The resinis offered in lightproof1kg PE bottles alongwith a programmedchip (referred to asTAG), which isrequired for use withthe 3D printer. TheTAG containsinformationidentifying the resinmaterial, name andamount. The E-Guardresin is an alternativematerial to heat-curedand auto-polymerizingresins. EnvisionTECsPerfactory DDP(Digital Dental Printer)models designed foruse with the E-Guardlight cured resin are:Perfactory DDP4 XL;Perfactory DesktopDDP plus; PerfactoryDesktop Pixera plus;Perfactory DDP4 M;Perfactory DDP Mini;Perfactory DDP MiniXL; Perfactory Vida 2;Perfactory Vida 2 Hi-RES; Perfactory VidaHD cDLM; PerfactoryVida cDLM; PerfactoryP4K 35, 62, 75, 90;Perfactory | reason for nopredicate for thisindication. | |
| Element | Harvest Printable Resin(Proposed Device) | NextDent Denture/E-Denture(Primary Predicate) | E-Guard(Secondary Predicate) | Comparison |
| Indications For Use | Harvest Printable Resin isindicated for the fabricationof dental bases for fullremovable dentures,artificial teeth, dental bitesplints and guards and try-indevices, i.e., denture baseand teeth. The material is analternative to traditionalheat-curable and auto-polymerizing resins and isintended for professionaldental work only. Thismaterial is intended to beused by dental labtechnicians and approved bylicensed practitioners beforebeing provided to thepatient. | NextDent Denture/ E-Denture is a light-curedresin indicated for thefabrication of denturebases fabricated in dentallaboratories, including fulland partial removabledentures. The material isan alternative totraditional heat cured andauto polymerizationresins. NextDentDenture/ E-Denture isintended exclusively forprofessional dental work.Fabrication of denturebases with NextDentDenture/ E-Denturerequires a computer-aided and manufacturing(CAD/CAM) system thatincludes the following:scanner, design software,additive printer, andpost-cure unit. NextDentDenture/ E-Denture iscompatible with thefollowing CAD/CAMsystems components -3Shape D900 scanner,3Shape Dental-System2016-Premium designsoftware, EnvisionTECDDP 4 printer usingPerfactory software,Rapidshape D30 printerusing NetFabb software,Micraft 125Y printer usingMiiUtility MiiControllersoftware, 3D systemsFigure 4 printer using 3DSprint software, RolandDG DWP-80S Printerusing Ver1.1 software, | MicroPlusXL;PerfactoryEnvisionOne cDLM.E-Guard is a light-cured resin. It is apolymer used tocreate removablestructures fortherapeuticrestorations, i.e., biteguards/splints andocclusal nightguards/splints usingthe AdditiveManufacturingprocess. The resin incombination with ascanner, printer, andcuring unit make upthe system. | The resins areindicated for usein printingdenture basesand/or ascustom bitesplints andguards.Note: Artificialteeth are 510(k)exempt and thereason for nopredicate for thisindication. |
| Element | Harvest Printable Resin(Proposed Device) | NextDent Denture/E-Denture(Primary Predicate) | E-Guard(Secondary Predicate) | Comparison |
| and NextDent LC-3DPrintBox post-curing unit. | ||||
| Curing Mechanism | Light-cure | Light-cure | Light-cure | Same |
| Technique | Additive Manufacturing(3D printing) | Additive Manufacturing(3D printing) | AdditiveManufacturing(3D printing) | Same |
| Basic ChemicalComposition | Methacrylates, urethanemethacrylates, photoinitiators and pigments | Dimethacrylate-basedresins with photo-initiator and pigments | Acrylates,methacrylates,methacrylatedoligomers andmonomers, photoinitiators,colorants/dyes andabsorbers. | Similar - Allmethacrylate-based light-cureresins withcolorants andphoto initiators. |
| Ultimate FlexuralStrength(ISO 20795-1) | 81.6 MPa≥ 65 MPa | 84 MPa≥ 65 MPa | N/A | Same - PassedISO 20795-1requirements |
| Ultimate FlexuralStrength(ISO 20795-2) | 81.6 MPa≥ 50 MPa | N/A | 79.4 - 85.1 MPa≥ 50 MPa | Same - PassedISO 20795-2requirements |
| Flexural Modulus(ISO 20795-1) | 2,339 MPa≥ 2,000 MPa | 2,383 MPa≥ 2,000 MPa | N/A | Same - PassedISO 20795-1requirements |
| Flexural Modulus(ISO 20795-2) | 2,339 MPa≥ 1,500 MPa | N/A | 2050-2130 MPa≥ 1,500 MPa | Same - PassedISO 20795-2requirements |
| Water Sorption(ISO 20795-1) | 24.3 µg/mm³≤ 32 µg/mm³ | 28 µg/mm³≤ 32 µg/mm³ | N/A | Same - PassedISO 20795-1requirements |
| Water Sorption(ISO 20795-2) | 24.3 µg/mm³≤ 32 µg/mm³ | N/A | 30- 32 µg/mm³≤ 32 µg/mm³ | Same - PassedISO 20795-2requirements |
| Water Solubility(ISO 20795-1) | 1.1 µg/mm³≤ 1.6 µg/mm³ | 0.1 µg/mm³≤ 1.6 µg/mm³ | N/A | Same - PassedISO 20795-1requirements |
| Water Solubility(ISO 20795-2) | 1.1 µg/mm³≤ 5 µg/mm³ | N/A | 0.5 µg/ mm³≤ 5 µg/mm³ | Same - PassedISO 20795-2requirements |
| Element | Harvest Printable Resin(Proposed Device) | NextDent Denture/E-Denture(Primary Predicate) | E-Guard(Secondary Predicate) | Comparison |
| Residual Monomer | None, no methylmethacrylate (MMA)monomers used forproduction. | ≤ 0.1 % (w/w)≤ 2.2% (w/w) | Unknown | Proposed deviceeliminateschances ofresidual Methylmethacrylate(MMA)monomers andassociatedbiocompatibilityissues by notutilizing MMAmonomersduringproduction. |
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Image /page/5/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features the words "HarvestDental" in a bold, sans-serif font, with "Harvest" in gray and "Dental" in green. Above the text is a green leaf design, and below the text are the words "LABORATORY PRODUCTS" in a smaller, gray font.
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Image /page/6/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features the word "Harvest" in gray and "Dental" in green. Above the words are two green leaves, one larger than the other. Below the words "Harvest Dental" are the words "Laboratory Products" in gray.
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Image /page/7/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features the words "HarvestDental" in a stylized font, with "Harvest" in gray and "Dental" in green. Above the text is a green plant with two leaves. Below the text is the phrase "LABORATORY PRODUCTS" in smaller, gray font.
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Image /page/8/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features two green leaves above the words "Harvest Dental" in gray. Below "Harvest Dental" are the words "Laboratory Products" in a smaller, gray font. The overall design is clean and professional, suggesting a focus on natural or organic dental products.
7. Performance Data
Biocompatibility Testing
The biocompatibility evaluation for the Harvest Printable Resin was conducted in accordance with ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry. Annex A. and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process" as recognized by FDA. The biocompatibility testing included the following tests:
-
- Cytotoxicity
-
- Sensitization
-
- Intracutaneous Reactivity
The biocompatibility testing conducted demonstrates adequate biocompatibility for the Harvest Printable Resin.
ISO 20795-1 & -2 Testing
Testing according to ISO 20795-1:2013 Dentistry - Base polymers, Part 1: Denture base polymers and ISO 20795-2:2013 Dentistry - Base polymers, Part 2: Orthodontic base polymers was performed on the Harvest Printable Resin and as compared to the predicate devices, it is substantially equivalent to the devices and met the physical/mechanical properties of the standard.
Clinical Studies
No human clinical testing was conducted to support substantial equivalence.
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Image /page/9/Picture/0 description: The image shows the logo for Harvest Dental Laboratory Products. The logo features two green leaves above the words "HarvestDental" in gray. Below "HarvestDental" are the words "LABORATORY PRODUCTS" in a smaller, gray font.
8. Conclusion as to Substantial Equivalence
The similarities in chemical composition, function and intended use of the Harvest Printable Resin with the legally marketed predicate devices, NextDent Denture/E-Denture (K162572) and E-Guard (K201173) support substantial equivalence.
§ 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.