(96 days)
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).
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.
The provided document is a 510(k) premarket notification for a dental device, Harvest Dental HD Gum Strip. It details the device's characteristics and its substantial equivalence to a predicate device, Gradia Gum. However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device. The document primarily focuses on biocompatibility and mechanical property testing for a physical dental material. Therefore, most of the requested information regarding AI/ML device evaluation is not present in this document.
Here's the information that can be extracted or inferred based on the provided text, with many fields explicitly stated as "Not Applicable" for an AI/ML device, as this document is not about one.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance (Harvest Dental HD Gum Strip) |
|---|---|
| Biocompatibility (ISO 7405:2018, ISO 10993-1) | Adequately demonstrated biocompatibility through Cytotoxicity, Sensitization, and Oral Mucosa Irritation tests. |
| Flexural Strength (ISO 10477:2020) | 77 MPa (> 50 MPa required by standard) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable as this is not an AI/ML device studying a dataset. The testing refers to physical material property tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable as this is not an AI/ML device. Ground truth for material properties is established through standardized physical tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as this is not an AI/ML device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable as this is not an AI/ML device. No human-in-the-loop studies were conducted for this physical dental material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable as this is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For physical material properties, the "ground truth" is defined by the standards and methods used in the specified ISO tests (ISO 7405 and ISO 10477).
8. The sample size for the training set
Not applicable as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable as this is not an AI/ML device.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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 (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
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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)
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:
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 872.3690Denture, Relining, Repairing, Rebasing Resin, per 21 CFR 872.3760 |
| Device Class: | II |
| Product Code: | EBFEBI |
| 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
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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 GumStrip(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 DentalProfessionals andTechnicians | Certified DentalProfessionals andTechnicians | Same |
| Common Name | Composite resin forgingival area of dentalprostheses | Composite resin forgingival area of dentalprostheses | Same |
| Device | Harvest Dental HD Gum | Gradia Gum is a light-cured | Similar - Harvest |
| Description | Strip is a bondable, light-cured composite for addingtexture and color to thegingival area of a dentalprosthesis which includescrowns, bridges and full andpartial prostheses. Thiscomposite strip is bondableto polymethylmethacrylate | composite resin used forthe reproduction ofgingival tissues by means ofbasic or multiple layeringtechniques. The material isapplied using a build-uptechnique, color adjustedusing modifiers andtextured. | Dental HD GumStrip is providedin a strip formrather than apaste form forease ofapplication andconsistentthickness. |
| Element | Harvest Dental HD GumStrip(Proposed Device) | Gradia Gum(Primary Predicate) | Comparison |
| (PMMA), metals andceramics (zirconia). It isprovided in a textured,malleable strip meant to beapplied to a dentine/bone-like substructure. The stripis an alternative to themethod of using a shadedcomposite paste tomanually build-up andmodel visible gingivalsurfaces to look similar tonatural gingival tissues. TheHarvest Dental HD GumStrip includes features suchas gingival veins formedinto its surface as well asbeing available in variousshades of coloration. Thestrip can be easily cut,applied to the gingivalsurface of the restoration,then trimmed and finishedwith appropriate featuressuch as gingival line andinterdental papilla. GumStrip Modifiers (pasteversions of the samecomposite) are available invarious shades and used foradditional surface featuresand gingival repairs, andLiquid Modifiers (stains,which are a low-viscositycolor-concentrated form ofthe same composite) areavailable in several shadesand used for enhancedcoloration resembling thenatural gingiva. TheHarvest Dental HD GumStrip is bonded to the | |||
| Element | Harvest Dental HD GumStrip(Proposed Device) | Gradia Gum(Primary Predicate) | Comparison |
| bonding adhesive providedwith the strip and modifiersand, after any final detailingand coloring, is to be curedutilizing a typical light-curing device. The HarvestDental HD Gum Strip is tobe used by dental labtechnicians and approvedby licensed dentalpractitioners before beingprovided to the patient. | |||
| Indications ForUse | Harvest Dental HD GumStrip is indicated for addingtexture, form and color tothe gingival area of a dentalprosthesis which includescrowns, bridges and fulland partial prostheses.This composite strip isbondable topolymethylmethacrylate(PMMA), as well as metalsand ceramics (zirconia). | Gradia Gum is a light-curedcomposite resin specificallyused for the reproductionof the gum on crown andbridge prostheses. | Same - Indicatedto reproduce thegingival area(gum) on dentalprostheses. |
| CuringMechanism | Light-Cure | Light-Cure | Same |
| Technique | Manual application | Manual application, build-up | Similar - HarvestDental HD GumStrip does notrequire anybuild-up. |
| Material Type | Urethane methacrylate,dimethacrylate,trimethacrylate, silica | Urethane dimethacrylate(UDMA), dimethacrylate,trimethacrylate, silica | Same |
| FlexuralStrength(ISO 10477) | 77 MPa> 50 MPa | 124Mpa> 50 MPa | Same - PassedISO 10477requirement |
| Element | Harvest Dental HD GumStrip(Proposed Device) | Gradia Gum(Primary Predicate) | Comparison |
| VickersHardness | N/ANo direct masticatoryforces on device | 38Hv | Not defined forSubject device. |
| Occlusal Wear(vs bovine'senamel, after200,000 times) | N/ANo occlusal contactintended | 170μ | Not defined forSubject device. |
| StorageConditions | 5-30°C,protect against directsunlight | Store in a cool place awayfrom 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:
-
- 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.
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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.
-
- 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
§ 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.