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 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.

AI/ML Overview

The provided text describes a medical device, "Harvest Conceal ZR Block Out," and its substantial equivalence determination by the FDA. However, the document does not contain the specific information requested in the prompt regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment relevant to AI/ML device performance.

The document states that:

No human clinical testing was conducted. This implies there would be no data on multi-reader multi-case studies or effect sizes of human readers with AI assistance.
The device is a "Liquid Stain for Dental Zirconia Restorations," which suggests it is a material used in the fabrication of dental products, not a diagnostic or prognostic AI/ML device.
Performance testing was "Bench Testing" for physical characteristics, and "Biocompatibility Testing" was conducted in accordance with ISO standards.

Therefore, I cannot extract the requested information such as a table of acceptance criteria and reported device performance, sample sizes for test sets, number of experts, adjudication methods, MRMC studies, standalone performance, or details about training sets and their ground truth, because this information is not present in the provided text. The document is primarily focused on the device's substantial equivalence to a predicate device based on material properties and intended use, not on the performance of an AI/ML algorithm.

Summary

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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)

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:

1. 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

1. 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

1. 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 BlockOut(Proposed Device)	DMAX Coloring Liquid;Chang's Liquid; ConfidentColoring Liquid; CAMeleonColoring Liquid(Primary Predicate)	Comparison
Manufacturer	Harvest Dental Products,LLC	DMAX Co, Ltd.	N/A
510(k)	K222961	K173769	N/A
Target Users	Certified DentalProfessionals andTechnicians	Certified DentalProfessionals andTechnicians	Same
Common Name	Liquid Stain for DentalZirconia Restorations	Liquid Stain for DentalZirconia Prosthesis	Same
DeviceDescription	Harvest Conceal ZR BlockOut is a water-basedsolution available in 5shades, white, A1, B1, C1and D2, for use with atranslucent zirconia core.It is indicated for burn-inzirconia shading. Theapplied liquid is sinteredwith the zirconia to adjustthe restoration to matchthe natural color of thepatient's teeth. Fabricationusing the Harvest ConcealZR Block Out requires anappropriate drying ovenand sintering furnace.	DMAX Coloring Liquid;Chang's Liquid; ConfidentColoring Liquid; CAMeleonColoring Liquid is a water-based solution used for theindividual staining of dentalzirconia frameworks andrestorations prior to thefinal sintering. It enablestrained dental techniciansto adjust the restoration tomatch the natural color ofthe patient's teeth.	Same
Indications ForUse	Harvest Conceal ZR BlockOut is indicated for burn-inzirconia shading. Theapplied liquid is sinteredwith the zirconia to adjustthe restoration to matchthe natural color of thepatient's teeth. Thematerial is intended for	DMAX coloring liquid,Chang's liquid, Confidentcoloring liquid, andCAMeleon coloring liquidcan be used as anaccessory to zirconiadioxide dental restorativematerial to provideindividual tooth (or teeth)	Same - Indicatedfor shading thezirconiarestorations tomatch thenatural color ofthe patient'steeth.
Element	Harvest Conceal ZR BlockOut(Proposed Device)	DMAX Coloring Liquid;Chang's Liquid; ConfidentColoring Liquid; CAMeleonColoring Liquid(Primary Predicate)	Comparison
	professional dental workonly.	shading. It is intended tobe used solely by certifieddental technicians for thefabrication of zirconiadioxide restorations forindividual dental patients.
Principles ofOperations	Manual brushing methodto zirconia framework,followed by drying andsintering processes.	Manual brushing orimmersion method tozirconia framework,followed by drying andsintering processes.	Same
Material Type	Water-based opaqueliquid, inorganic pigments(Water,Iron(hydroxide)oxides, ironOxide, sodium silicatesolution, magnesium oxide,calcium oxide, titaniumdioxide)	Water-based with inorganicpigments (Water, nickel (II)chloride hexahydrate, iron(III) nitrate nonahydrate,sodium silicate solution,manganese (II) nitratehexahydrate, erbium (III)nitrate pentahydrate,copper (II) nitratetrihydrate, chromium (III)nitrate nonahydrate)	Similar -differences inspecific 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 inWater	100%	100%	Same
StorageConditions	2-28°C,protect against directsunlight	2-28°C,protect against directsunlight	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
1. Sensitization
1. 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.

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
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.(b)
Classification. Class II.