Harvest Dental HD Gum Strip

K231389 · Harvest Dental Products, LLC · EBI · Aug 16, 2023 · Dental

Device Facts

• Record ID: K231389
• Device Name: Harvest Dental HD Gum Strip
• Applicant: Harvest Dental Products, LLC
• Product Code: EBI · Dental
• Decision Date: Aug 16, 2023
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3760
• Device Class: Class 2

Intended Use

Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis, which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).

Device Story

Harvest Dental HD Gum Strip is a light-cured, textured, malleable composite resin strip; used by dental lab technicians to add gingival texture, form, and color to dental prostheses (crowns, bridges, full/partial). Input: manual application of strip to dentine/bone-like substructure of prosthesis; includes gingival vein features. Output: finished gingival surface on dental restoration. Operation: strip cut to size, applied, trimmed, finished, and light-cured using standard dental light-curing device. Includes optional paste/liquid modifiers for repair and enhanced coloration. Benefit: provides an alternative to manual build-up of shaded composite paste; improves efficiency and consistency in modeling natural-looking gingival tissues. Final restoration approved by licensed dental practitioner before patient use.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including biocompatibility (cytotoxicity, sensitization, oral mucosa irritation) per ISO 7405 and ISO 10993-1, and physical/mechanical property testing per ISO 10477 (flexural strength 77 MPa, exceeding the 50 MPa requirement).

Technological Characteristics

Light-cured composite resin; materials: urethane methacrylate, dimethacrylate, trimethacrylate, silica. Form factor: textured, malleable strip. Curing: standard dental light-curing device. Standards: ISO 10477 (polymer-based crown/bridge materials), ISO 7405 (biocompatibility), ISO 10993-1 (biological evaluation).

Indications for Use

Indicated for adding texture, form, and color to the gingival area of dental prostheses (crowns, bridges, full/partial prostheses) in patients requiring gingival restoration. Bondable to PMMA, metals, and zirconia.

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

• Gradia Gum (K033808)

Submission Summary (Full Text)

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August 16, 2023

Harvest Dental Products, LLC Colleen Boswell Regulatory Affairs Consultant 905 Columbia Street Brea, California 92821

Re: K231389

Trade/Device Name: Harvest Dental HD Gum Strip Regulation Number: 21 CFR 872.3760 Regulation Name: Denture Relining, Repairing, Or Rebasing Resin Regulatory Class: Class II Product Code: EBI, EBF Dated: May 20, 2023 Received: July 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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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.

Michael E. Adjodha -S

Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.

Submission Number (if known)

K231389

Device Name

Harvest Dental HD Gum Strip

Indications for Use (Describe)

Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).

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:

2.

3.

Harvest Dental Products, LLC 905 Columbia Street Brea, California 92821

| Contact Person: | Colleen Boswell |
|--------------------------|----------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date Prepared: | July 25, 2023 |
| <b>Device:</b> | |
| Name of Device: | Harvest Dental HD Gum Strip |
| Common Name: | Composite resin for gingival area of dental prosthesis |
| Classification Name: | Tooth Shade Resin Material, per 21 CFR 872.3690<br>Denture, Relining, Repairing, Rebasing Resin, per 21 CFR 872.3760 |
| Device Class: | II |
| Product Code: | EBF<br>EBI |
| <b>Predicate Device:</b> | |
| Primary Predicate: | Gradia Gum, GC America, Inc., K033808, Product Code EBF & EBI |

#### 4. Device Description

Harvest Dental HD Gum Strip is a bondable, light-cured composite for adding texture and color to the gingival area of a dental prosthesis which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia). It is provided in a textured, malleable strip meant to be applied to a dentine/bone-like substructure. The strip is an alternative to the method of using a shaded composite paste to manually build-up and model visible gingival surfaces to look similar to natural gingival tissues. The Harvest Dental HD Gum Strip includes features such as gingival veins formed into its surface as well as being available in various shades of coloration. The strip can be easily cut, applied to the gingival surface of the restoration, then trimmed and finished with appropriate features such as gingival line and interdental papilla. Gum Strip Modifiers (paste versions of the same composite) are available in various shades and used for additional surface features and gingival repairs, and Liquid Modifiers (stains, which are a low-viscosity color-concentrated form of the same composite) are available in several shades and used for enhanced coloration resembling the natural gingiva. The Harvest Dental HD Gum Strip is bonded to the dental prosthesis

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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 "HarvestDental" in a stylized font, with "Harvest" in gray and "Dental" in a darker shade. Above the text is a green leaf design, with one large leaf and a smaller leaf below it. Underneath the company name, the words "LABORATORY PRODUCTS" are written in smaller, gray font.

utilizing a bonding adhesive provided with the strip and modifiers and, after any final detailing and coloring, is to be cured utilizing a typical light-curing device.

The Harvest Dental HD Gum Strip is to be used by dental lab technicians and approved by licensed dental practitioners before being provided to the patient.

## 5. Statement of Intended Use:

Harvest Dental HD Gum Strip is indicated for adding texture, form and color to the gingival area of a dental prosthesis, which includes crowns, bridges and full and partial prostheses. This composite strip is bondable to polymethylmethacrylate (PMMA), metals and ceramics (zirconia).

## 6. Summary of Technological Characteristics with the Predicate Device

The technological characteristics of the subject Harvest Dental HD Gum Strip are similar to the predicate device, Gradia Gum (K033808). There are no substantial technical or functional differences between Harvest Dental HD Gum Strip and the predicate device in terms of chemical composition, function and intended use. Both are composite resins used to reproduce the gingival area (gum) on dental prostheses. See Table 1 below for technological characteristics and comparisons of the composite resin for the gingival area of dental prostheses.

| Element | Harvest Dental HD Gum<br>Strip<br>(Proposed Device) | Gradia Gum<br>(Primary Predicate) | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Harvest Dental Products,<br>LLC | GC America, Inc. | N/A |
| 510(k) | K231389 | K033808 | N/A |
| Target Users | Certified Dental<br>Professionals and<br>Technicians | Certified Dental<br>Professionals and<br>Technicians | Same |
| Common Name | Composite resin for<br>gingival area of dental<br>prostheses | Composite resin for<br>gingival area of dental<br>prostheses | Same |
| Device | Harvest Dental HD Gum | Gradia Gum is a light-cured | Similar - Harvest |
| Description | Strip is a bondable, light-<br>cured composite for adding<br>texture and color to the<br>gingival area of a dental<br>prosthesis which includes<br>crowns, bridges and full and<br>partial prostheses. This<br>composite strip is bondable<br>to polymethylmethacrylate | composite resin used for<br>the reproduction of<br>gingival tissues by means of<br>basic or multiple layering<br>techniques. The material is<br>applied using a build-up<br>technique, color adjusted<br>using modifiers and<br>textured. | Dental HD Gum<br>Strip is provided<br>in a strip form<br>rather than a<br>paste form for<br>ease of<br>application and<br>consistent<br>thickness. |
| Element | Harvest Dental HD Gum<br>Strip<br>(Proposed Device) | Gradia Gum<br>(Primary Predicate) | Comparison |
| | (PMMA), metals and<br>ceramics (zirconia). It is<br>provided in a textured,<br>malleable strip meant to be<br>applied to a dentine/bone-<br>like substructure. The strip<br>is an alternative to the<br>method of using a shaded<br>composite paste to<br>manually build-up and<br>model visible gingival<br>surfaces to look similar to<br>natural gingival tissues. The<br>Harvest Dental HD Gum<br>Strip includes features such<br>as gingival veins formed<br>into its surface as well as<br>being available in various<br>shades of coloration. The<br>strip can be easily cut,<br>applied to the gingival<br>surface of the restoration,<br>then trimmed and finished<br>with appropriate features<br>such as gingival line and<br>interdental papilla. Gum<br>Strip Modifiers (paste<br>versions of the same<br>composite) are available in<br>various shades and used for<br>additional surface features<br>and gingival repairs, and<br>Liquid Modifiers (stains,<br>which are a low-viscosity<br>color-concentrated form of<br>the same composite) are<br>available in several shades<br>and used for enhanced<br>coloration resembling the<br>natural gingiva. The<br>Harvest Dental HD Gum<br>Strip is bonded to the | | |
| Element | Harvest Dental HD Gum<br>Strip<br>(Proposed Device) | Gradia Gum<br>(Primary Predicate) | Comparison |
| | bonding adhesive provided<br>with the strip and modifiers<br>and, after any final detailing<br>and coloring, is to be cured<br>utilizing a typical light-<br>curing device. The <b>Harvest</b><br><b>Dental HD Gum Strip</b> is to<br>be used by dental lab<br>technicians and approved<br>by licensed dental<br>practitioners before being<br>provided to the patient. | | |
| Indications For<br>Use | <b>Harvest Dental HD Gum<br/>Strip</b> is indicated for adding<br>texture, form and color to<br>the gingival area of a dental<br>prosthesis which includes<br>crowns, bridges and full<br>and partial prostheses.<br>This composite strip is<br>bondable to<br>polymethylmethacrylate<br>(PMMA), as well as metals<br>and ceramics (zirconia). | Gradia Gum is a light-cured<br>composite resin specifically<br>used for the reproduction<br>of the gum on crown and<br>bridge prostheses. | Same - Indicated<br>to reproduce the<br>gingival area<br>(gum) on dental<br>prostheses. |
| Curing<br>Mechanism | Light-Cure | Light-Cure | Same |
| Technique | Manual application | Manual application, build-<br>up | Similar - <b>Harvest<br/>Dental HD Gum<br/>Strip</b> does not<br>require any<br>build-up. |
| Material Type | Urethane methacrylate,<br>dimethacrylate,<br>trimethacrylate, silica | Urethane dimethacrylate<br>(UDMA), dimethacrylate,<br>trimethacrylate, silica | Same |
| Flexural<br>Strength<br>(ISO 10477) | 77 MPa<br>> 50 MPa | 124Mpa<br>> 50 MPa | Same - Passed<br>ISO 10477<br>requirement |
| Element | Harvest Dental HD Gum<br>Strip<br>(Proposed Device) | Gradia Gum<br>(Primary Predicate) | Comparison |
| Vickers<br>Hardness | N/A<br>No direct masticatory<br>forces on device | 38Hv | Not defined for<br>Subject device. |
| Occlusal Wear<br>(vs bovine's<br>enamel, after<br>200,000 times) | N/A<br>No occlusal contact<br>intended | 170μ | Not defined for<br>Subject device. |
| Storage<br>Conditions | 5-30°C,<br>protect against direct<br>sunlight | Store in a cool place away<br>from direct sunlight | Similar |

#### Table 1: Comparison of Subject and Predicate Devices

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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 stylized font, with "Harvest" in gray and "Dental" in green. Above the text is an image of two green leaves. Below the text is the phrase "LABORATORY PRODUCTS" in 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 words "HarvestDental" in a stylized font, with "Harvest" in gray and "Dental" in green. Above the text is an image of two green leaves. Below the text is the phrase "LABORATORY PRODUCTS" in smaller, gray font.

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Image /page/7/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 that, the words "LABORATORY PRODUCTS" are written in a smaller, gray font.

# 7. Performance Data

# Biocompatibility Testing

The biocompatibility evaluation for Harvest Dental HD Gum Strip 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
- 2. Sensitization
- 3. Oral Mucosa Irritation

The biocompatibility testing conducted demonstrates adequate biocompatibility for Harvest Dental HD Gum Strip.

# ISO 10477 Testing

Testing according to ISO 10477:2020 Dentistry. Polymer-based crown and bridge materials was performed on the Harvest Dental HD Gum Strip is applied directly to a crown (or bridge) and becomes part of that device. As compared to the predicate device, it is substantially equivalent to the device 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/8/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, performance testing and intended use of Harvest Dental HD Gum Strip with the legally marketed predicate device, Gradia Gum (K033808) support substantial equivalence.