(96 days)
Not Found
No
The device description and performance studies focus on the material properties and application method of a composite strip for dental prostheses, with no mention of AI or ML technologies.
No
The device is a composite material used to add aesthetic features to dental prostheses, not to treat a disease or condition.
No
The device is a composite material used for adding texture, form, and color to dental prostheses, not for diagnosing any medical condition.
No
The device is a physical composite strip and associated materials used for dental prostheses, not software.
Based on the provided information, the Harvest Dental HD Gum Strip is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to add texture, form, and color to the gingival area of a dental prosthesis. This is a restorative and aesthetic purpose, not a diagnostic one.
- Device Description: The description details a material used to build up and model the appearance of gingival tissue on a dental restoration. It's a physical component applied to a prosthesis.
- Lack of Diagnostic Function: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information about a disease, condition, or state of health.
- Anatomical Site: The anatomical site is the "gingival area of a dental prosthesis," which is an artificial structure, not a part of the living human body being tested for diagnostic purposes.
- Performance Studies: The performance studies focus on biocompatibility and physical/mechanical properties, which are relevant for a material used in dental prosthetics, not for diagnostic accuracy.
IVD devices are specifically designed to perform tests on samples taken from the human body to aid in diagnosis, monitoring, or screening. The Harvest Dental HD Gum Strip does not fit this definition. It is a dental material used in the fabrication of dental prostheses.
N/A
Intended Use / Indications for 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).
Product codes
EBI, EBF
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
gingival area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental lab technicians and approved by licensed dental practitioners
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 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:
-
- Cytotoxicity
-
- Sensitization
-
- Oral Mucosa Irritation
The biocompatibility testing conducted demonstrates adequate biocompatibility for Harvest Dental HD Gum Strip.
- Oral Mucosa Irritation
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
Submission Number (if known)
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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3
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: | July 25, 2023 |
| Device: | |
| 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 |
| Denture, Relining, Repairing, Rebasing Resin, per 21 CFR 872.3760 | |
| Device Class: | II |
| Product Code: | EBF |
| EBI | |
| Predicate Device: | |
| 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
4
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
Strip
(Proposed Device) | Gradia Gum
(Primary Predicate) | Comparison |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Harvest Dental Products,
LLC | GC America, Inc. | N/A |
| 510(k) | K231389 | K033808 | N/A |
| Target Users | Certified Dental
Professionals and
Technicians | Certified Dental
Professionals and
Technicians | Same |
| Common Name | Composite resin for
gingival area of dental
prostheses | Composite resin for
gingival area of dental
prostheses | Same |
| Device | Harvest Dental HD Gum | Gradia Gum is a light-cured | Similar - Harvest |
| Description | 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 | composite resin used for
the reproduction of
gingival tissues by means of
basic or multiple layering
techniques. The material is
applied using a build-up
technique, color adjusted
using modifiers and
textured. | Dental HD Gum
Strip is provided
in a strip form
rather than a
paste form for
ease of
application and
consistent
thickness. |
| Element | Harvest Dental HD Gum
Strip
(Proposed Device) | Gradia Gum
(Primary Predicate) | Comparison |
| | (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 | | |
| Element | Harvest Dental HD Gum
Strip
(Proposed Device) | Gradia Gum
(Primary Predicate) | Comparison |
| | 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. | | |
| Indications For
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), as well as metals
and ceramics (zirconia). | Gradia Gum is a light-cured
composite resin specifically
used for the reproduction
of the gum on crown and
bridge prostheses. | Same - Indicated
to reproduce the
gingival area
(gum) on dental
prostheses. |
| Curing
Mechanism | Light-Cure | Light-Cure | Same |
| Technique | Manual application | Manual application, build-
up | Similar - Harvest
Dental HD Gum
Strip does not
require any
build-up. |
| Material Type | Urethane methacrylate,
dimethacrylate,
trimethacrylate, silica | Urethane dimethacrylate
(UDMA), dimethacrylate,
trimethacrylate, silica | Same |
| Flexural
Strength
(ISO 10477) | 77 MPa
50 MPa | 124Mpa
50 MPa | Same - Passed
ISO 10477
requirement |
| Element | Harvest Dental HD Gum
Strip
(Proposed Device) | Gradia Gum
(Primary Predicate) | Comparison |
| Vickers
Hardness | N/A
No direct masticatory
forces on device | 38Hv | Not defined for
Subject device. |
| Occlusal Wear
(vs bovine's
enamel, after
200,000 times) | N/A
No occlusal contact
intended | 170μ | Not defined for
Subject device. |
| Storage
Conditions | 5-30°C,
protect against direct
sunlight | Store in a cool place away
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.
6
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.
7
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:
-
- Cytotoxicity
-
- Sensitization
-
- 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.
8
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.
-
- 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.
- Conclusion as to Substantial Equivalence