(248 days)
Not Found
No
The device description and intended use focus on a water-based opacifying solution for zirconia shading, with no mention of AI or ML technologies. Performance studies are limited to biocompatibility and bench testing of physical characteristics.
No
The device is used for shading zirconia dental restorations to match natural tooth color, which is a cosmetic and material processing function, not a therapeutic one that treats, diagnoses, cures, mitigates, or prevents disease.
No
The device is described as an "opacifying solution" used to adjust the color of dental restorations. Its purpose is to match the natural color of teeth, and it is not described as analyzing or interpreting any biological data to diagnose a condition.
No
The device description clearly states it is a "water-based opacifying solution" and requires a drying oven and sintering furnace, indicating it is a physical material and not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "burn-in zirconia shading" to adjust the color of dental restorations. This is a process performed on a material (zirconia) that will be placed in the patient's mouth, not a test performed on a sample taken from the patient to diagnose or monitor a condition.
- Device Description: The description details a liquid used to color zirconia, which is then sintered. This is a material processing step for a dental prosthetic.
- Lack of IVD Characteristics: There is no mention of analyzing a biological sample (blood, urine, tissue, etc.), detecting a disease or condition, or providing information for diagnosis, monitoring, or treatment decisions based on a patient sample.
The device is clearly intended for use in the fabrication of dental restorations, which falls under the category of dental materials or devices, not in vitro diagnostics.
N/A
Intended Use / 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.
Product codes
EIH
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.
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
professional dental work only.
Certified Dental Professionals and Technicians
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 was conducted in accordance with ISO 7405:2018 and ISO 10993-1, including Cytotoxicity, Sensitization, and Oral Mucosa Irritation tests. The results demonstrated adequate biocompatibility.
Performance Testing (Bench Testing) was conducted for the physical characteristics and found the device substantially equivalent to the predicate.
No human clinical testing was conducted.
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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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
1
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
2
Indications for Use
Submission Number (if known)
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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510(k) Summary
K222961
-
- Submitter:
Harvest Dental Products, LLC 905 Columbia Street Brea, California 92821
- Submitter:
| Contact Person: | Colleen Boswell |
|---|---|
| Telephone Number: | (714) 674-7400 |
| Fax Number: | (714) 674-7402 |
Mav 2. 2023 Date Prepared:
-
- 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 |
-
- Predicate Device:
Primary Predicate:
- Predicate Device:
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.
-
- 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.
- Statement of Intended Use:
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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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
Out
(Proposed Device) | DMAX Coloring Liquid;
Chang's Liquid; Confident
Coloring Liquid; CAMeleon
Coloring Liquid
(Primary Predicate) | Comparison |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Harvest Dental Products,
LLC | DMAX Co, Ltd. | N/A |
| 510(k) | K222961 | K173769 | N/A |
| Target Users | Certified Dental
Professionals and
Technicians | Certified Dental
Professionals and
Technicians | Same |
| Common Name | Liquid Stain for Dental
Zirconia Restorations | Liquid Stain for Dental
Zirconia Prosthesis | Same |
| Device
Description | Harvest Conceal ZR Block
Out is a water-based
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. | DMAX Coloring Liquid;
Chang's Liquid; Confident
Coloring Liquid; CAMeleon
Coloring Liquid is a water-
based solution used for the
individual staining of dental
zirconia frameworks and
restorations prior to the
final sintering. It enables
trained dental technicians
to adjust the restoration to
match the natural color of
the patient's teeth. | Same |
| 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 | DMAX coloring liquid,
Chang's liquid, Confident
coloring liquid, and
CAMeleon coloring liquid
can be used as an
accessory to zirconia
dioxide dental restorative
material to provide
individual tooth (or teeth) | Same - Indicated
for shading the
zirconia
restorations to
match the
natural color of
the patient's
teeth. |
| Element | Harvest Conceal ZR Block
Out
(Proposed Device) | DMAX Coloring Liquid;
Chang's Liquid; Confident
Coloring Liquid; CAMeleon
Coloring Liquid
(Primary Predicate) | Comparison |
| | professional dental work
only. | shading. It is intended to
be used solely by certified
dental technicians for the
fabrication of zirconia
dioxide restorations for
individual dental patients. | |
| Principles of
Operations | Manual brushing method
to zirconia framework,
followed by drying and
sintering processes. | Manual brushing or
immersion method to
zirconia framework,
followed by drying and
sintering processes. | Same |
| Material Type | Water-based opaque
liquid, inorganic pigments
(Water,
Iron(hydroxide)oxides, iron
Oxide, sodium silicate
solution, magnesium oxide,
calcium oxide, titanium
dioxide) | Water-based with inorganic
pigments (Water, nickel (II)
chloride hexahydrate, iron
(III) nitrate nonahydrate,
sodium silicate solution,
manganese (II) nitrate
hexahydrate, erbium (III)
nitrate pentahydrate,
copper (II) nitrate
trihydrate, chromium (III)
nitrate nonahydrate) | Similar -
differences in
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
Water | 100% | 100% | Same |
| Storage
Conditions | 2-28°C,
protect against direct
sunlight | 2-28°C,
protect against direct
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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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 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.