Harvest Printable Resin

K222489 · Harvest Dental Products, LLC · EBI · May 12, 2023 · Dental

Device Facts

• Record ID: K222489
• Device Name: Harvest Printable Resin
• Applicant: Harvest Dental Products, LLC
• Product Code: EBI · Dental
• Decision Date: May 12, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended 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.

Device Story

Harvest Printable Resin is a light-cured resin for additive manufacturing (3D printing) of dental appliances; specifically denture bases, artificial teeth, bite splints, and guards. The process involves using a CAD/CAM system and a digital light processing (DLP) printer to generate the device from a solid model, followed by post-processing in a UV light curing unit for final polymerization. The device is intended for use in dental laboratories by technicians, with final approval by licensed practitioners. It is optimized for use with specific Asiga and Sprintray printers and curing units. The resin serves as an alternative to traditional heat-curable and auto-polymerizing resins. By enabling 3D-printed fabrication, it allows for customized dental restorations, potentially improving workflow efficiency and precision in dental appliance manufacturing.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, intracutaneous reactivity per ISO 10993-1 and ISO 7405:2018) and mechanical property testing (flexural strength, flexural modulus, water sorption, and water solubility) per ISO 20795-1 and ISO 20795-2.

Technological Characteristics

Light-cured resin composed of methacrylates, urethane methacrylates, photo initiators, and pigments. Form factor is liquid resin for 3D printing. Requires CAD/CAM system, DLP printer, and UV curing unit. Complies with ISO 20795-1 and ISO 20795-2 for mechanical properties. Biocompatibility per ISO 10993-1 and ISO 7405:2018. No MMA monomers used.

Indications for Use

Indicated for fabrication of dental bases for full removable dentures, artificial teeth, dental bite splints, guards, and try-in devices. Intended for professional dental use by lab technicians, subject to approval by licensed practitioners.

Regulatory Classification

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.

Predicate Devices

• NextDent Denture/E-Denture (K162572)
• E-Guard (K201173)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

K222489

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

- 1. Submitter:
Harvest Dental Products, LLC 905 Columbia Street Brea, California 92821

| Contact Person: | Colleen Boswell |
|-------------------|-----------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |

Date Prepared: April 23, 2023

- 2. 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 |

- 3. Predicate Device:

| Primary Predicate: | <i>NextDent Denture/E-Denture</i> , Vertex-Dental B.V., K162572, Product Code EBI |
|----------------------|-----------------------------------------------------------------------------------|
| Secondary Predicate: | <i>E-Guard</i> , 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<br>(Proposed Device) | NextDent Denture/<br>E-Denture<br>(Primary Predicate) | E-Guard<br>(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 | Healthcare<br>facility/hospital, dental<br>(technical) laboratory | Dental laboratories<br>and dental practices | Same |
| Common Name | Printable Resin | Printable Resin | Printable Resin | Same |
| Device Description | Harvest Printable Resin is<br>light-cured resin developed<br>for additive manufacturing<br>(3D printing) of individual full<br>denture bases, artificial<br>teeth, bite splints and guards<br>and try-in devices, i.e.,<br>denture base and teeth.<br>After being utilized in a 3D<br>stereolithographic printer to<br>generate a dental device<br>based on a solid model, the<br>device is placed in a UV light | NextDent Denture/ E-<br>Denture 3D-printing<br>material is a light-cured<br>resin indicated for the<br>manufacturing of denture<br>bases. The material is<br>used in a 3D printer,<br>which prints the shape<br>determined by a 3D<br>stereolithographic<br>drawing. After printing,<br>the printed product is<br>placed in a UV-light | The E-Guard system<br>combines a scanner<br>with design software,<br>the light-cured resin, a<br>3D printer and a<br>curing unit. These<br>components are used<br>together during the<br>manufacture of the<br>dental appliance<br>splint/bite guard. The<br>light-curing resin is<br>composed of acrylate/ | Same. The<br>resins are used<br>in the 3D<br>printing of<br>dental devices<br>including<br>denture bases,<br>bite splits and<br>guards.<br>Note: Artificial<br>teeth are 510(k)<br>exempt and the |
| Element | Harvest Printable Resin<br>(Proposed Device) | NextDent Denture/<br>E-Denture<br>(Primary Predicate) | E-Guard<br>(Secondary Predicate) | Comparison |
| | curing unit for final<br>polymerization.<br><br>Fabrication using <b>Harvest Printable Resin</b> requires an<br>appropriate computer-aided<br>Design and Manufacturing<br>(CAD/CAM) system, a digital<br>light processing (DLP)<br>printer, and post-processing<br>light curing equipment. It<br>has been optimized for use<br>with Asiga (Max UV, Pro<br>4K65 and Pro 4K80) and<br>Sprintray (Pro95 S and Pro55<br>S) printers and, therefore,<br>may only be used in<br>conjunction with these<br>printers and their associated<br>software systems. It is also<br>only to be used in<br>conjunction with Asiga (Max<br>UV, Pro 4K65 and Pro 4K80)<br>and Sprintray (Procure and<br>Procure 2) curing units for<br>post-processing.<br><br>The 3D printer is not<br>included with the device. | curing box for final<br>polymerization.<br><br>3D printer is not included<br>with the device. | methacrylate,<br>methacrylated<br>oligomers and<br>monomers, photo<br>initiators,<br>colorants/dyes and<br>absorbers. It is used<br>by dental laboratories<br>and dental practices<br>to make customized<br>bite splints, using the<br>3D-printer. The resin<br>is offered in lightproof<br>1kg PE bottles along<br>with a programmed<br>chip (referred to as<br>TAG), which is<br>required for use with<br>the 3D printer. The<br>TAG contains<br>information<br>identifying the resin<br>material, name and<br>amount. The E-Guard<br>resin is an alternative<br>material to heat-cured<br>and auto-polymerizing<br>resins. EnvisionTECs<br>Perfactory DDP<br>(Digital Dental Printer)<br>models designed for<br>use with the E-Guard<br>light cured resin are:<br>Perfactory DDP4 XL;<br>Perfactory Desktop<br>DDP plus; Perfactory<br>Desktop Pixera plus;<br>Perfactory DDP4 M;<br>Perfactory DDP Mini;<br>Perfactory DDP Mini<br>XL; Perfactory Vida 2;<br>Perfactory Vida 2 Hi-<br>RES; Perfactory Vida<br>HD cDLM; Perfactory<br>Vida cDLM; Perfactory<br>P4K 35, 62, 75, 90;<br>Perfactory | reason for no<br>predicate for this<br>indication. |
| Element | Harvest Printable Resin<br>(Proposed Device) | NextDent Denture/<br>E-Denture<br>(Primary Predicate) | E-Guard<br>(Secondary Predicate) | Comparison |
| Indications For Use | Harvest Printable Resin is<br>indicated for the fabrication<br>of dental bases for full<br>removable dentures,<br>artificial teeth, dental bite<br>splints and guards and try-in<br>devices, i.e., denture base<br>and teeth. The material is an<br>alternative to traditional<br>heat-curable and auto-<br>polymerizing resins and is<br>intended for professional<br>dental work only. This<br>material is intended to be<br>used by dental lab<br>technicians and approved by<br>licensed practitioners before<br>being provided to the<br>patient. | NextDent Denture/ E-<br>Denture is a light-cured<br>resin indicated for the<br>fabrication of denture<br>bases fabricated in dental<br>laboratories, including full<br>and partial removable<br>dentures. The material is<br>an alternative to<br>traditional heat cured and<br>auto polymerization<br>resins. NextDent<br>Denture/ E-Denture is<br>intended exclusively for<br>professional dental work.<br>Fabrication of denture<br>bases with NextDent<br>Denture/ E-Denture<br>requires a computer-<br>aided and manufacturing<br>(CAD/CAM) system that<br>includes the following:<br>scanner, design software,<br>additive printer, and<br>post-cure unit. NextDent<br>Denture/ E-Denture is<br>compatible with the<br>following CAD/CAM<br>systems components -<br>3Shape D900 scanner,<br>3Shape Dental-System<br>2016-Premium design<br>software, EnvisionTEC<br>DDP 4 printer using<br>Perfactory software,<br>Rapidshape D30 printer<br>using NetFabb software,<br>Micraft 125Y printer using<br>MiiUtility MiiController<br>software, 3D systems<br>Figure 4 printer using 3D<br>Sprint software, Roland<br>DG DWP-80S Printer<br>using Ver1.1 software, | MicroPlusXL;<br>Perfactory<br>EnvisionOne cDLM.<br><br>E-Guard is a light-<br>cured resin. It is a<br>polymer used to<br>create removable<br>structures for<br>therapeutic<br>restorations, i.e., bite<br>guards/splints and<br>occlusal night<br>guards/splints using<br>the Additive<br>Manufacturing<br>process. The resin in<br>combination with a<br>scanner, printer, and<br>curing unit make up<br>the system. | The resins are<br>indicated for use<br>in printing<br>denture bases<br>and/or as<br>custom bite<br>splints and<br>guards.<br><br>Note: Artificial<br>teeth are 510(k)<br>exempt and the<br>reason for no<br>predicate for this<br>indication. |
| Element | Harvest Printable Resin<br>(Proposed Device) | NextDent Denture/<br>E-Denture<br>(Primary Predicate) | E-Guard<br>(Secondary Predicate) | Comparison |
| | | and NextDent LC-3DPrint<br>Box post-curing unit. | | |
| Curing Mechanism | Light-cure | Light-cure | Light-cure | Same |
| Technique | Additive Manufacturing<br>(3D printing) | Additive Manufacturing<br>(3D printing) | Additive<br>Manufacturing<br>(3D printing) | Same |
| Basic Chemical<br>Composition | Methacrylates, urethane<br>methacrylates, photo<br>initiators and pigments | Dimethacrylate-based<br>resins with photo-<br>initiator and pigments | Acrylates,<br>methacrylates,<br>methacrylated<br>oligomers and<br>monomers, photo<br>initiators,<br>colorants/dyes and<br>absorbers. | Similar - All<br>methacrylate-<br>based light-cure<br>resins with<br>colorants and<br>photo initiators. |
| Ultimate Flexural<br>Strength<br>(ISO 20795-1) | 81.6 MPa<br>≥ 65 MPa | 84 MPa<br>≥ 65 MPa | N/A | Same - Passed<br>ISO 20795-1<br>requirements |
| Ultimate Flexural<br>Strength<br>(ISO 20795-2) | 81.6 MPa<br>≥ 50 MPa | N/A | 79.4 - 85.1 MPa<br>≥ 50 MPa | Same - Passed<br>ISO 20795-2<br>requirements |
| Flexural Modulus<br>(ISO 20795-1) | 2,339 MPa<br>≥ 2,000 MPa | 2,383 MPa<br>≥ 2,000 MPa | N/A | Same - Passed<br>ISO 20795-1<br>requirements |
| Flexural Modulus<br>(ISO 20795-2) | 2,339 MPa<br>≥ 1,500 MPa | N/A | 2050-2130 MPa<br>≥ 1,500 MPa | Same - Passed<br>ISO 20795-2<br>requirements |
| Water Sorption<br>(ISO 20795-1) | 24.3 µg/mm³<br>≤ 32 µg/mm³ | 28 µg/mm³<br>≤ 32 µg/mm³ | N/A | Same - Passed<br>ISO 20795-1<br>requirements |
| Water Sorption<br>(ISO 20795-2) | 24.3 µg/mm³<br>≤ 32 µg/mm³…