(282 days)
Not Found
No
The device description and performance studies focus on the material properties and intended use for milling dental prosthetics, with no mention of AI or ML.
No
The device is described as "industrialized polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems." This indicates it is a material for fabricating dental restorations, not a therapeutic device itself.
No
The device is described as "dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges," indicating it is used for manufacturing dental prosthetics, not for diagnosing medical conditions.
No
The device description clearly states it is a physical product (polymer blocks) used for milling dental prosthetics, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics." This describes a material used to create dental restorations and appliances that are placed in the patient's mouth.
- Device Description: The description reinforces this, stating they are "dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges... or bite splints."
- Lack of IVD Characteristics: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information about a physiological state, disease, or condition. IVDs are used in vitro (outside the body) to analyze these samples.
The device is a material used in the manufacturing of dental prosthetics, which are medical devices, but not IVDs.
N/A
Intended Use / Indications for Use
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
-Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) - Removable appliances (splint)
Product codes (comma separated list FDA assigned to the subject device)
EBG, EBI, MQC
Device Description
Harvest Dental Polymer Blocks are industrially polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems.
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
Not Found
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)
Preclinical testing included biocompatibility tests and physical property tests.
Biocompatibility tests for "Harvest Dental Polymer Blocks" included:
- ISO 10993-10, 2010: Harvest Dental Polymer Blocks was classified as no sensitizing.
- ISO 10993-10, annex B3 2010: Harvest Dental Polymer Blocks was classified as non-irritant to oral mucose of hamsters.
- ISO 10993-5, 2009 annex C: Harvest Dental Polymer Blocks did not promote reduction of cell viability higher than 30%, hence it was not cytotoxic.
Physical property tests were conducted according to DIN EN ISO 20795-1 / ISO 10477 standards for comparison with the predicate device:
- Flexural strength: Submission device Value > 90 Mpa (Required > 65 MPa for ISO 20795-1, or > 50 MPa for ISO 10477). Passed.
- Water absorption: Submission device Value 0.024 mg/mm³ (Required ≤ 32 µg/mm³ for ISO 20795-1, or ≤ 40 µg/mm³ for ISO 10477). Passed.
- Water solubility: Submission device Value 0.0000 mg/mm³ (Required ≤ 1.6 µg/mm³ for ISO 20795-1, or ≤ 7.5 µg/mm³ for ISO 10477). Passed.
- Residual monomer content [%]: Submission device Value
§ 872.3770 Temporary crown and bridge resin.
(a)
Identification. A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.(b)
Classification. Class II.
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Harvest Dental Products, LLC Sasha Der Avanessian Owner 905 Columbia Street Brea, California 92821
December 12, 2018
Re: K180578
Trade/Device Name: Harvest Dental Polymer Blocks Regulation Number: 21 CFR 872.3770 Regulation Name: Temporary Crown And Bridge Resin Regulatory Class: Class II Product Code: EBG, EBI, MQC Dated: September 14, 2018 Received: September 14, 2018
Dear Sasha Der Avanessian:
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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely, Digitally signed by Mary S. Mary S. F Runner - S3 rvically -5:
Runner -S33 - Date: 2018.12.12 14:33:57
Runner -S33 - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K180578
Device Name Harvest Dental Polymer Blocks
Indications for Use (Describe)
Indications for Use:
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
-Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth) - Removable appliances (splint)
Type of Use (Select one or both, as applicable)
X 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 words "HarvestDental" in a gray sans-serif font. Below the company name are the words "LABORATORY PRODUCTS" in a smaller, gray sans-serif font.
K180578 510(k) Summary
This Summary of 510K safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
| 510K Submitter | Harvest Dental Products, LLC
905 Columbia St, Brea, CA 92821
Tel: 714-674-7400
hello@harvestdental.com |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------|
| Contact person: | Sasha Der Avanessian
President & CEO
Tel: 714-674-7400
sasha@harvestdental.com |
| Date Summary was prepared | 12/11/18 |
| Trade Name of device: | Harvest Dental Polymer Blocks |
| Common name: | Crown & Bridge, Temporary, Resin |
| Classification name: | TEMPORARY CROWN AND BRIDGE RESIN. (21 CFR 872.3770 - Product code EBG) |
| Classification Product Code | EBG |
| Panel | Dental |
| Classification | Class II |
| Predicate Device | K150432
Union Dental S.A
Idodentine (Dental Polymer Blank) |
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Image /page/4/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 the text is the phrase "LABORATORY PRODUCTS" in a smaller, gray font.
Indications for Use:
For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics.
- Provisional anterior and posterior crowns & bridges
- Implant and abutment supported prosthetics.
- Partial, complete and hybrid denture prosthetics (base and teeth)
- Removable appliances (splint)
Device Description:
Harvest Dental Polymer Blocks are industrially polymerized, pre-colored or clear dental milling discs and blocks designed for milled fabrication of temporary anterior and posterior crowns and bridges (tooth-colored variants) or bite splints and dental CAD/CAM systems.
Technological characteristics
The technologic characteristics are highly similar as demonstrated in performance testing and in chemical composition; both devices are composed primarily of polymethylmethacrylate, while the amount and percentage of color oxides in the submission device varies from the predicate.
Comparison of Required Technology Characteristics
The following table shows a summary of the technological characteristics of DD medical polymers compared to the predicate device.
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Image /page/5/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" also in gray.
| Feature | Submission device | Predicate device |
|---|---|---|
| Trade name | Harvest Dental Polymer Blank | Idodentine Disc |
| 510 (K) | K180578 | K150432 |
| Product code | EBG | EBG |
| Regulatory Class | CLASS II | Class II |
| Manufacturer | Harvest Dental | Union Dental S.A |
| Indications for use | For the fabrication of crowns, bridges and structures for implant supported provisional removable denture and appliance prosthetics. - Provisional anterior and posterior crowns & bridges. - Implant and abutment supported prosthetics. - Partial, complete and hybrid denture prosthetics (base and teeth). - Removable appliances (splint) | Acrylic polymer blank particularly suitable for making removable or temporary dental structures such as crowns and bridges using milling technology using CAD/CAM. Indications - Temporary anterior and posterior crowns - Temporary anterior and posterior bridges with up to two adjacent pontics Maximum recommended usage period: 12 months - Removable structures for dentures (denture bases) - Removable structures for therapeutic restorations (bite splints or occlusal splints) |
| Technology | Blank for dental CAD/CAM | Blank for dental CAD/CAM |
| Shape | Disc or Block | Disc or Block |
| Shade | VITA-shades, clear, pink | VITA-shades, clear, pink |
| Raw Material | PMMA | PMMA |
| Chemical Compositions [Units] | ||
| Material Base | Polymethyl methacrylate | Polymethyl methacrylate |
| Coloring oxides | 90 | |
| Mpa | 90 [MPa] | Passed |
| Water | ||
| absorption | ≤ 32 | |
| [µg/mm³] | ≤ 40 | |
| [µg/mm³] | 0.024 | |
| mg/mm³ | 23 | |
| [µg/mm³] | Passed | |
| Water | ||
| solubility | ≤ 1.6 | |
| [µg/mm³] | ≤ 7.5 | |
| [µg/mm³] | 0.0000 | |
| mg/mm³ | 0.0 | |
| [µg/mm³] | Passed | |
| Residual | ||
| monomer | ||
| content [%] | ≤ 2.2 % | - |