Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a printable resin material and its intended use in 3D printing dental devices. There is no mention of AI or ML technology being incorporated into the resin itself or the associated manufacturing process described. The required CAD/CAM system and printer software are mentioned, but not in a way that suggests AI/ML capabilities.

Therapeutic

No.
This device is a material (resin) used to fabricate dental devices like denture bases and bite splints, not a therapeutic device itself.

Diagnostic

No

The device is a light-cured resin used for fabricating dental bases, artificial teeth, and bite splints, which are physical dental devices, not diagnostic tools. Its intended use is for "fabrication" and it is described as "material" for professional dental work.

SaMD (Software as a Medical Device)

No

The device is a light-cured resin material used for 3D printing dental devices. It is a physical material, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the fabrication of dental devices (denture bases, artificial teeth, bite splints, guards, try-in devices). This is a manufacturing process for a medical device that will be used in the patient's mouth, not a test performed on a sample taken from the patient to provide diagnostic information.
Device Description: The device is a light-cured resin used in a 3D printing process to create physical dental devices. This is a material used in the fabrication of a medical device, not a diagnostic test kit or instrument.
No mention of analyzing samples: There is no indication that this device is used to analyze any biological samples (blood, urine, tissue, etc.) to provide diagnostic information about a patient's health.

IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

EBI, ELM, MQC

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.

The 3D printer is not included with the device.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

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.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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:

1. Cytotoxicity
1. Sensitization
1. 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Ultimate Flexural Strength (ISO 20795-1): 81.6 MPa (≥ 65 MPa)
Ultimate Flexural Strength (ISO 20795-2): 81.6 MPa (≥ 50 MPa)
Flexural Modulus (ISO 20795-1): 2,339 MPa (≥ 2,000 MPa)
Flexural Modulus (ISO 20795-2): 2,339 MPa (≥ 1,500 MPa)
Water Sorption (ISO 20795-1): 24.3 µg/mm³ (≤ 32 µg/mm³)
Water Sorption (ISO 20795-2): 24.3 µg/mm³ (≤ 32 µg/mm³)
Water Solubility (ISO 20795-1): 1.1 µg/mm³ (≤ 1.6 µg/mm³)
Water Solubility (ISO 20795-2): 1.1 µg/mm³ (≤ 5 µg/mm³)
Residual Monomer: None, no methyl methacrylate (MMA) monomers used for production.

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K162572, K201173

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 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.

Summary

0

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

1

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

2

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:	(714) 674-7400
Fax Number:	(714) 674-7402

Date Prepared: April 23, 2023

1. 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

1. 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 (Proposed Device) E-Denture
(Primary Predicate) (Secondary Predicate) |-------------------- | Manufacturer | 510(k) | Target Users facility/hospital, dental
(technical) laboratory and dental practices | Common Name | Device Description 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 Denture 3D-printing
material is a light-cured
resin indicated for the
manufacturing of denture
bases. The material is
used in a 3D printer,
which prints the shape
determined by a 3D
stereolithographic
drawing. After printing,
the printed product is
placed in a UV-light combines a scanner
with design software,
the light-cured resin, a
3D printer and a
curing unit. These
components are used
together during the
manufacture of the
dental appliance
splint/bite guard. The
light-curing resin is
composed of acrylate/ resins are used
in the 3D
printing of
dental devices
including
denture bases,
bite splits and
guards.
Note: Artificial
teeth are 510(k)
exempt and the | Element (Proposed Device) E-Denture
(Primary Predicate) (Secondary Predicate) | polymerization. | Harvest Printable Resin
| NextDent Denture/
| E-Guard
| Comparison |
----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Harvest Dental Products, LLC | Vertex-Dental B.V. | EnvisionTEC GmbH | N/A |
| K222489 | K162572 | K201173 | N/A |
| Dental laboratories | Healthcare
| Dental laboratories
| Same |
| Printable Resin | Printable Resin | Printable Resin | Same |
| Harvest Printable Resin is
| NextDent Denture/ E-
| The E-Guard system
| Same. The
|
| Harvest Printable Resin
| NextDent Denture/
| E-Guard
| Comparison |
| curing unit for final

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. | curing box for final
polymerization.

3D printer is not included
with the device. | methacrylate,
methacrylated
oligomers and
monomers, photo
initiators,
colorants/dyes and
absorbers. It is used
by dental laboratories
and dental practices
to make customized
bite splints, using the
3D-printer. The resin
is offered in lightproof
1kg PE bottles along
with a programmed
chip (referred to as
TAG), which is
required for use with
the 3D printer. The
TAG contains
information
identifying the resin
material, name and
amount. The E-Guard
resin is an alternative
material to heat-cured
and auto-polymerizing
resins. EnvisionTECs
Perfactory DDP
(Digital Dental Printer)
models designed for
use with the E-Guard
light cured resin are:
Perfactory DDP4 XL;
Perfactory Desktop
DDP plus; Perfactory
Desktop Pixera plus;
Perfactory DDP4 M;
Perfactory DDP Mini;
Perfactory DDP Mini
XL; Perfactory Vida 2;
Perfactory Vida 2 Hi-
RES; Perfactory Vida
HD cDLM; Perfactory
Vida cDLM; Perfactory
P4K 35, 62, 75, 90;
Perfactory | reason for no
predicate for this
indication. |
| Element | Harvest Printable Resin
(Proposed Device) | NextDent Denture/
E-Denture
(Primary Predicate) | E-Guard
(Secondary Predicate) | Comparison |
| 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. | NextDent Denture/ E-
Denture is a light-cured
resin indicated for the
fabrication of denture
bases fabricated in dental
laboratories, including full
and partial removable
dentures. The material is
an alternative to
traditional heat cured and
auto polymerization
resins. NextDent
Denture/ E-Denture is
intended exclusively for
professional dental work.
Fabrication of denture
bases with NextDent
Denture/ E-Denture
requires a computer-
aided and manufacturing
(CAD/CAM) system that
includes the following:
scanner, design software,
additive printer, and
post-cure unit. NextDent
Denture/ E-Denture is
compatible with the
following CAD/CAM
systems components -
3Shape D900 scanner,
3Shape Dental-System
2016-Premium design
software, EnvisionTEC
DDP 4 printer using
Perfactory software,
Rapidshape D30 printer
using NetFabb software,
Micraft 125Y printer using
MiiUtility MiiController
software, 3D systems
Figure 4 printer using 3D
Sprint software, Roland
DG DWP-80S Printer
using Ver1.1 software, | MicroPlusXL;
Perfactory
EnvisionOne cDLM.

E-Guard is a light-
cured resin. It is a
polymer used to
create removable
structures for
therapeutic
restorations, i.e., bite
guards/splints and
occlusal night
guards/splints using
the Additive
Manufacturing
process. The resin in
combination with a
scanner, printer, and
curing unit make up
the system. | The resins are
indicated for use
in printing
denture bases
and/or as
custom bite
splints and
guards.

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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:

1. Cytotoxicity
1. Sensitization
1. 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.