Harvest Conceal ZR Block Out
Device Facts
| Record ID | K222961 |
|---|---|
| Device Name | Harvest Conceal ZR Block Out |
| Applicant | Harvest Dental Products, LLC |
| Product Code | EIH · Dental |
| Decision Date | Jun 2, 2023 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.6660 |
| Device Class | Class 2 |
Indications for Use
Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.
Device Story
Harvest Conceal ZR Block Out is a water-based opacifying solution used by dental professionals/technicians to shade translucent zirconia restorations. Available in 5 shades (white, A1, B1, C1, D2), the liquid is applied to the zirconia framework via manual brushing. The restoration is then processed in a drying oven and sintering furnace. During sintering, the liquid integrates with the zirconia to adjust the final color, matching the patient's natural dentition. The device benefits patients by improving the aesthetic appearance of dental restorations.
Clinical Evidence
No clinical data provided. Substantial equivalence supported by bench testing of physical characteristics (boiling point, density, specific gravity, solubility) and biocompatibility testing (cytotoxicity, sensitization, oral mucosa irritation) conducted per ISO 7405:2018 and ISO 10993-1.
Technological Characteristics
Water-based opacifying solution containing inorganic pigments (Iron hydroxides/oxides, sodium silicate, magnesium oxide, calcium oxide, titanium dioxide). Physical properties: 100% water solubility, 1.05 g/cm³ density, 100°C boiling point. Application via manual brushing followed by drying and sintering. Storage: 2-28°C.
Indications for Use
Indicated for burn-in zirconia shading to adjust dental restorations to match natural tooth color. Intended for professional dental use only.
Regulatory Classification
Identification
Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.
Predicate Devices
- DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid (K173769)
Submission Summary (Full Text)
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June 2, 2023
Harvest Dental Products, LLC Colleen Boswell Regulatory Affairs Consultant 905 Columbia Street Brea, California 92821
Re: K222961
Trade/Device Name: Harvest Conceal ZR Block Out Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 2, 2023 Received: May 2, 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
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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 -5
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
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# Indications for Use
Submission Number (if known)
K222961
Device Name
Harvest Conceal ZR Block Out
#### Indications for Use (Describe)
Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.
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 company name. The word "Harvest" is in gray, while "Dental" is in green. Below the company name, the words "Laboratory Products" are written in gray.
## 510(k) Summary
## K222961
- 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 |
Mav 2. 2023 Date Prepared:
- 2. Device:
| Name of Device: | Harvest Conceal ZR Block Out |
|----------------------|--------------------------------------------------------|
| Common Name: | Liquid Stain for Dental Zirconia Restorations |
| Classification Name: | Porcelain Powder for Clinical Use, per 21 CFR 872.6660 |
| Device Class: | II |
| Product Code: | EIH |
- 3. Predicate Device:
Primary Predicate:
DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid, DMAX Co, Ltd., K173769, Product Code EIH
## 4. Device Description
Harvest Conceal ZR Block Out is a water-based opacifying solution available in 5 shades. white, A1, B1, C1 and D2, for use with a translucent zirconia core. It is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. Fabrication using the Harvest Conceal ZR Block Out requires an appropriate drying oven and sintering furnace.
- 5. Statement of Intended Use:
Harvest Conceal ZR Block Out is indicated for burn-in zirconia shading. The applied liquid is sintered with the zirconia to adjust the restoration to match the natural color of the patient's teeth. The material is intended for professional dental work only.
## 6. Summary of Technological Characteristics with the Predicate Device
The technological characteristics of the subject Harvest Conceal ZR Block Out is similar to the predicate device, DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid (K173769). There are no substantial technical or functional differences between Harvest Conceal ZR Block Out and the predicate device in terms of
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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 words "HarvestDental" in a combination of gray and green. Below the company name, the words "LABORATORY PRODUCTS" are written in gray.
chemical composition, function and intended use. Both are a water-based solutions used to shade/mask substructures when used with zirconia restorations. See Table 1 below for technological characteristics and comparisons of the liquid stain for dental zirconia restorations.
| Element | Harvest Conceal ZR Block<br>Out<br>(Proposed Device) | DMAX Coloring Liquid;<br>Chang's Liquid; Confident<br>Coloring Liquid; CAMeleon<br>Coloring Liquid<br>(Primary Predicate) | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Harvest Dental Products,<br>LLC | DMAX Co, Ltd. | N/A |
| 510(k) | K222961 | K173769 | N/A |
| Target Users | Certified Dental<br>Professionals and<br>Technicians | Certified Dental<br>Professionals and<br>Technicians | Same |
| Common Name | Liquid Stain for Dental<br>Zirconia Restorations | Liquid Stain for Dental<br>Zirconia Prosthesis | Same |
| Device<br>Description | Harvest Conceal ZR Block<br>Out is a water-based<br>solution available in 5<br>shades, white, A1, B1, C1<br>and D2, for use with a<br>translucent zirconia core.<br>It is indicated for burn-in<br>zirconia shading. The<br>applied liquid is sintered<br>with the zirconia to adjust<br>the restoration to match<br>the natural color of the<br>patient's teeth. Fabrication<br>using the Harvest Conceal<br>ZR Block Out requires an<br>appropriate drying oven<br>and sintering furnace. | DMAX Coloring Liquid;<br>Chang's Liquid; Confident<br>Coloring Liquid; CAMeleon<br>Coloring Liquid is a water-<br>based solution used for the<br>individual staining of dental<br>zirconia frameworks and<br>restorations prior to the<br>final sintering. It enables<br>trained dental technicians<br>to adjust the restoration to<br>match the natural color of<br>the patient's teeth. | Same |
| Indications For<br>Use | Harvest Conceal ZR Block<br>Out is indicated for burn-in<br>zirconia shading. The<br>applied liquid is sintered<br>with the zirconia to adjust<br>the restoration to match<br>the natural color of the<br>patient's teeth. The<br>material is intended for | DMAX coloring liquid,<br>Chang's liquid, Confident<br>coloring liquid, and<br>CAMeleon coloring liquid<br>can be used as an<br>accessory to zirconia<br>dioxide dental restorative<br>material to provide<br>individual tooth (or teeth) | Same - Indicated<br>for shading the<br>zirconia<br>restorations to<br>match the<br>natural color of<br>the patient's<br>teeth. |
| Element | Harvest Conceal ZR Block<br>Out<br>(Proposed Device) | DMAX Coloring Liquid;<br>Chang's Liquid; Confident<br>Coloring Liquid; CAMeleon<br>Coloring Liquid<br>(Primary Predicate) | Comparison |
| | professional dental work<br>only. | shading. It is intended to<br>be used solely by certified<br>dental technicians for the<br>fabrication of zirconia<br>dioxide restorations for<br>individual dental patients. | |
| Principles of<br>Operations | Manual brushing method<br>to zirconia framework,<br>followed by drying and<br>sintering processes. | Manual brushing or<br>immersion method to<br>zirconia framework,<br>followed by drying and<br>sintering processes. | Same |
| Material Type | Water-based opaque<br>liquid, inorganic pigments<br>(Water,<br>Iron(hydroxide)oxides, iron<br>Oxide, sodium silicate<br>solution, magnesium oxide,<br>calcium oxide, titanium<br>dioxide) | Water-based with inorganic<br>pigments (Water, nickel (II)<br>chloride hexahydrate, iron<br>(III) nitrate nonahydrate,<br>sodium silicate solution,<br>manganese (II) nitrate<br>hexahydrate, erbium (III)<br>nitrate pentahydrate,<br>copper (II) nitrate<br>trihydrate, chromium (III)<br>nitrate nonahydrate) | Similar -<br>differences in<br>specific pigments |
| Boiling Point | 100°C | 100°C | Same |
| Density | 1.05 g/cm³ | 1.00 ~ 1.10 g/cm³ | Same |
| Specific Gravity | 1.05 | 1.00 ~ 1.10 | Same |
| Solubility in<br>Water | 100% | 100% | Same |
| Storage<br>Conditions | 2-28°C,<br>protect against direct<br>sunlight | 2-28°C,<br>protect against direct<br>sunlight | Same |
## Table 1: Comparison of Subject and Predicate Devices
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## 7. Performance Data
# Biocompatibility Testing
The biocompatibility evaluation for Harvest Conceal ZR Block Out 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
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Image /page/6/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 and green. Below the words "HarvestDental" are the words "LABORATORY PRODUCTS" in gray.
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 Conceal ZR Block Out.
#### Performance Testing
Bench Testing was conducted for the physical characteristics of Harvest Conceal ZR Block Out and as compared to the predicate device, it is substantially equivalent.
#### Clinical Studies
No human clinical testing was conducted to support substantial equivalence.
#### 8. Conclusion as to Substantial Equivalence
The similarities in chemical composition, function, physical characteristics and intended use of Harvest Conceal ZR Block Out with the legally marketed predicate device, DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid (K173769) support substantial equivalence.
