(145 days)
Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.
Shaders™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in different sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM)". Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
The provided document is a 510(k) summary for a dental device (Shaders™ Zirconia blanks). It does not contain information about studies related to AI or digital healthcare device performance for diagnostics or image analysis. Therefore, I cannot extract the information requested about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical effectiveness studies in the context of AI.
The document discusses the physical and chemical properties of the Shaders™ Zirconia blanks and compares them to a predicate device (Glidewell Prismatik™ Clinical Zirconia) to demonstrate substantial equivalence.
Here's a breakdown of what is provided regarding the device's characteristics and how it meets physical/chemical criteria based on the document:
1. A table of acceptance criteria and the reported device performance
| Criteria (Acceptance Limit) | Reported Device Performance (Shaders™ Zirconia) | Comment (from document) |
|---|---|---|
| Material Composition | Same as predicate | |
| ZrO2+HfO2+Y2O3 | Provided (exact % not in this table) | |
| HfO2 | Provided (exact % not in this table) | |
| Y2O3 | Provided (exact % not in this table) | |
| Al2O3 | Provided (exact % not in this table) | |
| Other oxides | Provided (exact % not in this table) | |
| Freedom from extraneous materials per ISO 6872:2008 Section 5.2 active conc. of not more than 1.0 Bq g⁻¹ of Uranium238 | <0.03 | Passed test |
| Physical Properties | ||
| Sintered Density (No Req't, but $\geq$ 6.09 g cm³ listed in a separate table) | 6.09 g/cm⁻³ | No req't in comparison table (but meets $\geq$ limit in properties table) |
| Coefficient of thermal expansion (CTE) (No specific limit given, compared for similarity) | 10.1 μm/m °C | Both Materials are 3m% and will have the same density (referencing predicate) |
| Fracture toughness KIC (5.0 MPa m^(0.5)) | 5 MPa m^(0.5) | Same as predicate |
| Flexural strength per ISO 6872:2008, Limit >900MPa | 1103 MPa | Both close to 1100 mpa |
| Chemical solubility per ISO 6872:2008, Limit 100 µg/cm² | 18.1 µg/cm² | Test passed |
| Biocompatibility per ISO 10993-1: Part 1 | Assured through use of same materials and manufacturing methods as legally marketed predicate devices | Similar compositions and manufacturing methods. |
| Blank sizes(mm) | Disc: 98.5-100mm x 10-30mm thick | Same as predicate |
Additional Chemical Properties (from a separate table in the document):
| Component (chemical composition) | Shaders™ Zirconia (percentage by wt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3 + Al2O3 | > 99.9 |
| Y2O3 | 5.35 - 5.95 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
| Fe2O3 | ≤0.01 |
| Chemical solubility | 18.1 µg/cm² |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "sintered tests coupled with mechanical bench testing" to confirm specifications but does not detail the sample sizes or data provenance for these non-clinical 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)
This is not applicable as the document describes a material and its physical/chemical properties, not a diagnostic or AI device requiring expert ground truth establishment for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for the type of device and testing described.
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. This is not an AI-assisted device for human interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a dental material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance relies on established international standards for dental ceramic materials (ISO 6872:2008 and ISO 13356: 2008) and direct measurement of physical and chemical properties (e.g., density, flexural strength, chemical solubility, fracture toughness).
8. The sample size for the training set
Not applicable. This is a physical device, not an AI model.
9. How the ground truth for the training set was established
Not applicable.
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July 29, 2019
Digital Age Dental Lab Tim Mckimson International Project Manager 2110 Artesia Blvd. Ste. B-132 Redondo Beach, California 90278
Re: K190569
Trade/Device Name: Shaders ZR Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 22, 2019 Received: April 22, 2019
Dear Tim Mckimson:
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
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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 medical devices and radiation-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,
Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K190569
Device Name Shaders™ Zirconia
Indications for Use (Describe)
Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to creatic) prostheses (dentures, crowns, and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a dental laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.
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)
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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K190569
Page 11 of 82
July 10, 2019
510(k) Summary
for
Digital Age Dental Laboratories
Shaders™ Zirconia
Submitter 1.
Digital Age Dental Laboratories 3I A Dan Chu Street, VSIP 2, Hoa Phu Ward, Thu Dau Mot City, Binh Duong Province, Vietnam Phone: +84-650-3628 100 Fax: +84-650-3628 104 Contact Person: Tim McKimson Email: TMcKimson@fishmandentallabs.com
2. Device Name
| Proprietary Name: | Shaders™ Zirconia |
|---|---|
| Common/Usual Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use. |
| Regulation Number: | 21 CFR 872.6660 |
| Regulation Name: | Porcelain Powder for Clinical Use |
| Regulation Class: | II |
| Product Code: | EIH |
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3. Predicate Device:
Device Trade Name: Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ)
| 510 (k): | K062509 |
|---|---|
| Common/Usual Name: | Powder, Porcelain |
| Classification Name: | Porcelain powder for clinical use. |
| Regulation Number: | 21 CFR 872.6660 |
| Regulation Name: | Porcelain Powder for Clinical Use |
| Regulation Class: | II |
| Product Code: | FIH |
Indications for Use 4.
Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions.
5. Device Description and Function
Shaders™ Zirconia are disc shaped dental porcelain zirconia oxide blanks that come in different sizes that are used in custom restorations by the dental laboratory. The dental laboratory will further process the blank by milling the blank based upon the anatomically rendering of the patient's teeth (done at the dental
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office) through "Computer Aided Drafting/ Computer Aided Machining (CAD/CAM)". Once the custom rendered blank is milled the product is fully sintered and colored (if required) and fitted to the patient's teeth as dentures, crowns or bridges.
6. Substantial Equivalence
A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows:
| Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment |
|---|---|---|---|
| Indicationsfor use | Shaders™ Zirconia blanks are indicated for use in prosthetic dentistry to create porcelain (ceramic) prostheses (dentures, crowns and bridges). Shaders™ Zirconia blanks are intended to be milled and fully sintered by a Dental Professional or Dental Laboratory before use. Full contour monolithic crowns and bridges in anterior and posterior regions. | The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations. | No change |
| Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment |
| Contra-Indications | There are no specificprecautions, warnings orcontra-indications that arerequired for the safe andeffective use of the deviceby the dental professionalor patient. | There are no specificprecautions, warningsor contra-indicationsthat are required forthe safe and effectiveuse of the device bythe dental professionalor patient. | Same |
| MaterialComposition | Zirconia Powder: | Zirconia Powder: | Same |
| ZrO2+HfO2 + Y2O3 | ZrO2+HfO2+Y2O3 | ||
| HfO2 | HfO2 | ||
| Y2O3 | Y2O3 | ||
| Al2O3 | Al2O3 | ||
| Other oxides | Other oxides | ||
| Freedom fromextraneousmaterials perISO 6872:2008Section 5.2active conc. ofnot more than$1.0 Bq g^{-1}$ ofUranium238 | <0.03 | Not supplied | Passed test |
| SinteredDensity$g/cm^{-3}$No req't. | $6.09 g/cm^{-3}$ | Not supplied | No req't |
| Coefficient ofthermalexpansion(CTE) | $10.1 \mu m/m$ °C | Not supplied | Both Materialsare 3m% andwill have thesame density |
| Feature | Shaders™ Zirconia | Prismatik™ CZ | Comment |
| FracturetoughnessKIC | 5 MPa m0.5 | 5.0 MPa m0.5 | Same |
| Flexuralstrength perISO 6872:2008, Limit>900MPa | 1103 MPa | 1100MPa | Both close to1100 mpa |
| Chemicalsolubility perISO6872:2008Limit 100µg/cm² | 18.1 µg/cm² | Not supplied | Test passed |
| Biocompatibility per ISO10993-1: Part1 - 'Biologicalevaluation ofmedicaldevices –Part1: Evaluationand testingwithin a riskmanagementprocess." | Assured through use ofsame materials andmanufacturing methods aslegally marketed predicatedevices. | "The biological safetyof the device has beenassured through theselection of materialssimilar in compositionto the other productscurrently on the marketwhich havedemonstratedappropriate levels ofbiocompatibility (seesupra regardingmaterials and labelingfor the device)." | Similiarcompositionsandmanufacturingmethods. |
| Blanksizes(mm) | Disc:98.5-100mm x 10-30mmthick | Disc:98.5 x 10-30mm thick | Same |
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Page 14 of 82
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Physical and Performance Characteristics 7.
Material Used:
Shaders™ Zirconia blanks are composed of zirconia ceramics (ZrO2) based on yttria-stabilized tetragonal zirconia (Y-TZP). The material is biocompatible according to ISO 10993-1: 2009 "Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
Physical Properties:
Tabulated chart of finished product "Shaders™ Zirconia" blanks
| Sintered Density | $\geq$ 6.09 g cm³ |
|---|---|
| Thermal Expansion coefficient (20-500°C) | 10.1 µm/m °C |
| Bending Strength | > 900 MPa |
| Grain size | 0.45 µm |
| Fracture toughness | 5 MPam0.5 |
Chemical Properties:
| Component (chemicalcomposition) | Shaders™ Zirconia (percentage bywt.) |
|---|---|
| ZrO2 + HfO2 + Y2O3+ Al2O3 | > 99.9 |
| Y2O3 | 5.35 - 5.95 |
| Al2O3 | ≤0.1 |
| SiO2 | ≤0.02 |
| Fe2O3 | ≤0.01 |
| Chemical solubility | 18.1 µg/cm² |
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8. Nonclinical Testing
Digital Age Dental Laboratories performed a series of tests to assess whether the device is safe and effective to use. Sintered tests coupled with mechanical bench testing confirmed that the device meets specifications including established international standards and guidance documents. Density, bending strength, fracture toughness, chemical solubility and material characterization/composition of finished product was conducted to confirm that the product is safe and effective, while meeting performance goals established by standards. Shaders™ Zirconia blanks comply with ISO 6872:2008, "Dentistry – Ceramic materials" and ISO 13356: 2008, "Implants for surgery, Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP)".
9. Clinical Testing
Clinical tests have not been performed.
-
- Conclusion: Shaders™ Zirconia blank comparison to the predicate device Glidewell Prismatik™ Clinical Zirconia (Prismatik™ CZ K060104) is based upon similar characteristics such as: intended use, indications, contra-indications, material properties, chemical composition, processing/fabrication and testing to recognized standards and guidelines, Digital Age Dental believes that Shaders™ Zirconia blanks are substantially equivalent to these legally marketed predicate devices.
§ 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.