Obsidian® NOW is used to fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology. The block is processed through dental laboratories or by dental professionals.

Device Description

Obsidian® NOW is a fully crystallized lithium disilicate glass-ceramic block that can be milled to produce dental restorations using CAD/CAM technology. The block is intended to be used for fabricating monolithic restorations such as full contour crowns without requiring any additional crystallization prior to placement. The milling block is offered in the commonly used VITA® Classical and Chromascop® Bleach shades.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard)	Reported Device Performance
Material Properties
Flexural Strength: ≥300 MPa (ISO 6872:2015/Amd 1:2018, Type II Class 3)	Average flexural strength met the acceptance criteria of 300 MPa (Type II, Class 3)
Chemical Solubility: <100 µg/cm² (ISO 6872:2015/Amd 1:2018)	<100 µg/cm²
Radioactivity: Uranium-238 activity ≤ 1.0 Bq/g⁻¹ (ISO 6872:2015/Amd 1:2018)	Sample measured below the Uranium-238 activity threshold of 1.0 Bq-g-1
Freedom from Extraneous Materials: Assessed by visual inspection (ISO 6872:2015/Amd 1:2018)	All samples were free from extraneous materials when assessed by visual inspection
Glass Transition Temperature: Shall not deviate by more than ±20°C of the average T₀ (ISO 6872:2015/Amd 1:2018)	Samples did not deviate by more than ±20℃ of the average T₀ obtained across all lots
Biocompatibility: Per ISO 10993-1	Biocompatible per ISO 10993-1 (no biocompatibility concern based on cytotoxicity testing)
Aesthetic Properties
Visual Shade Evaluation: Meets visual shade match requirements	Meets visual shade match requirements
Color Consistency: ΔE < 2.0 within a batch (CEILAB color space)	ΔE calculation between samples was less than 2.00
Uniformity of Color: Uniform in color (visual inspection, ISO 6872:2015/Amd 1:2018)	All samples milled into restorations from a representative final finished block were uniform in color
Packaging
Packaging Validation: Suitable to withstand distribution environment (ASTM D4169-22)	Respective packaging for Obsidian® NOW is suitable for use (withstood manual handling, vehicle stacking, loose load vibration, low pressure, vehicle vibration, and concentrated impact, with no visual damage to shipping containers)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the exact sample sizes for each specific test within the "test set" (non-clinical tests). However, for many tests, it mentions that "all shades offered for Obsidian® NOW" were tested or "the worst cases were tested."

Flexural Strength: Tested on "all shades offered for Obsidian® NOW."
Visual Shade Evaluation: "All shades offered for Obsidian® NOW were evaluated."
Color Consistency: Tested on "all shades offered for Obsidian® NOW."
Uniformity of Color: Tested on "all shades offered for Obsidian® NOW."
Chemical Solubility: "The worst cases were tested."
Radioactivity: "Tested on the worst cases."
Freedom from Extraneous Materials: "All shades offered for Obsidian® NOW were tested."
Glass Transition Temperature: "All shades offered for Obsidian® NOW were tested."
Biocompatibility: Based on "cytotoxicity testing results from the subject device." Implies testing on representative samples.
Packaging Validation: Tested on "Obsidian® NOW" packaging.

The data provenance is retrospective as these are non-clinical lab tests performed on the manufactured device, not on actual patients. The document does not specify the country of origin for the data; it would typically be the location of the testing laboratories.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

Visual Shade Evaluation: "qualified evaluators" were used. Their specific number or qualifications (e.g., years of experience, dental professional titles) are not specified in this document.
For other tests like "Freedom from Extraneous Materials" and "Uniformity of Color," visual inspection by unspecified personnel established the ground truth.

4. Adjudication Method for the Test Set:

Given that many of the tests are objective laboratory measurements (e.g., flexural strength, chemical solubility, radioactivity, glass transition temperature, color consistency ΔE calculation), an adjudication method (like 2+1 or 3+1) is not applicable as there is no subjective interpretation to resolve.

For the qualitative visual inspections (Visual Shade Evaluation, Freedom from Extraneous Materials, Uniformity of Color), the document mentions evaluations by "qualified evaluators" or "visual inspection," but it does not specify any formal adjudication method if multiple evaluators were involved or disagreed. It simply states the evaluations "concluded" or "assessed."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported. This submission specifically states: "No clinical data is included in this submission." The studies presented are non-clinical (laboratory and in-vitro performance tests).

6. Standalone (Algorithm Only) Performance Study:

No, a standalone (algorithm only) performance study was not conducted or reported. This device is a physical material (a glass-ceramic milling block) used in dentistry, not an AI algorithm or software. Therefore, the concept of "algorithm only performance" is not relevant to this submission. The device itself is the "standalone" component being evaluated.

7. Type of Ground Truth Used:

The ground truth for the non-clinical tests was established by:

Objective laboratory measurements: This applies to Flexural Strength, Chemical Solubility, Radioactivity, Glass Transition Temperature, and Color Consistency (ΔE calculation). The "truth" is the measured physical or chemical property of the material.
Expert Consensus/Visual Inspection: For Visual Shade Evaluation, Freedom from Extraneous Materials, and Uniformity of Color, the ground truth was established by visual assessment by "qualified evaluators" or general visual inspection against established standards (e.g., VITA® Classical shade guide).
Biocompatibility Standard (ISO 10993-1): The ground truth for biocompatibility was adherence to the testing requirements and criteria outlined in this international standard.
Packaging Standard (ASTM D4169-22): The ground truth for packaging validation was successful completion of tests outlined in this standard, confirmed by visual inspection for damage.

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this device. This is a physical dental material, not an AI/ML algorithm or software that requires training data. The document describes non-clinical performance testing of the final manufactured product.

9. How the Ground Truth for the Training Set Was Established:

As mentioned above, a "training set" is not applicable here since the device is a physical material and not an AI/ML system.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 27, 2024

Prismatik Dentalcraft. Inc. Nina Chiang Regulatory Affairs Specialist 2144 Michelson Dr. Irvine, California 92612

Re: K234014

Trade/Device Name: Obsidian® NOW Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: December 19, 2023 Received: December 19, 2023

Dear Nina Chiang:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).

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Sincerely,

Michael E. Adjodha -S

Michael Adjodha, MChE, RAC, 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)

Device Name

Obsidian® NOW

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/4/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient that starts with blue at the bottom and transitions to pink at the top. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC.", in blue sans-serif font.

510(k) Summary

K234014

Date Prepared: February 20, 2024

I. Contact Details

Applicant Name: Prismatik Dentalcraft, Inc.

Applicant Address: 2144 Michelson Drive, Irvine, CA 92612 United States

Applicant Contact Telephone: 949-222-3516

Applicant Contact: Ms. Nina Chiang, Regulatory Affairs Specialist

Applicant Contact Email: nina.chiang@glidewelldental.com

Secondary Contact: So Hyun Park, Regulatory Affairs Manager

Secondary Contact Email: so.park@glidewelldental.com

Secondary Contact Phone: 949-863-5479

II. Device Name

Device Trade Name: Obsidian® NOW

Common Name: Glass Ceramic Milling Block or Dental CAD/CAM Block

Classification Name: Porcelain powder for clinical use

Regulation Number: 872.6660

Product Code: EIH

III. Legally Marketed Predicate Device

Predicate 510(k) #: K141788

Predicate Trade Name: Obsidian Milling Blocks

Product Code: EIH

IV. Device Description

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Image /page/5/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangular shape with a color gradient. The colors in the triangle range from pink to blue to green to yellow. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.

V. Intended Use/Indications for Use

VI. Technological Comparison

The subject device, Obsidian® NOW, is substantially equivalent to the predicate device, Obsidian Milling Block (K141788) in intended use, material, design principles, and technological characteristics.

The subject device, Obsidian® NOW, has the same intended use as the predicate device, Obsidian Milling Block (K141788), as the material is used in fabrication of dental restorations such as crowns for the purpose of restoring function. The subject device, Obsidian® NOW, has the same indication for use except for the device trade name and the addition of a chairside indication for use where the blocks are processed through dental laboratories or by dental professionals.

The subject device, Obsidian® NOW, is substantially equivalent to the predicate device, Obsidian Milling Block (K141788) in technological characteristics. The same mechanical property testing in terms of flexural strength that was conducted on the predicate device, Obsidian Milling Block (K141788), was also conducted on the subject device, Obsidian® NOW, according to ISO 6872:2015/Amd 1:2018. The flexural strength of the subject device, Obsidian® NOW, met performance criteria in ISO 6872 for Type II, Class 3.

The subject device, Obsidian® NOW, and the predicate device, Obsidian Milling Block (K141788) are similar in material composition. Both devices utilize glass components as the base material, colorants, and opacifiers that make up the lithium aluminosilicate glass matrix. Despite the differences in the colorants and opacifiers to achieve the desired shades, the slight differences in chemical formulation do not affect the safety and effectiveness of the device as verified by the biocompatibility and performance testing.

The subject device, Obsidian® NOW, is substantially equivalent to the predicate device, Obsidian Milling Block (K141788) in terms of design. Both devices are offered in a block form in different shades and are used to make final dental restorations based on the anatomical rendering of patient's teeth using CAD/CAM equipment.

Attributes	Subject Device(K234014)	Predicate Device(K141788)	Comparison
Device Name	Obsidian® NOW	Obsidian MillingBlock	N/A
Manufacturer	Prismatik Dentalcraft,Inc.	Prismatik Dentalcraft,Inc.	Same
	Attributes	Subject Device(K234014)	Predicate Device(K141788)	Comparison
	Product Code	EIH	EIH	Same
	Prescription Device	Yes	Yes	Same
	Intended Use	Obsidian® NOW isintended to be used infabrication of dentalrestorations for thepurpose of restoringchewing function.	Obsidian MillingBlock is intended to beused in fabrication ofdental restorations forthe purpose ofrestoring chewingfunction.	Same; except forthe device tradename.
	Indications for Use	Obsidian® NOW isused to fabricateceramic dentalprosthesis in thenature of crowns forposterior and anteriorapplications usingCAD/CAMtechnology. The blockis processed throughdental laboratories orby dentalprofessionals.	The Obsidian MillingBlocks are used tofabricate ceramicdental prostheses inthe nature of crownsand bridges forposterior and anteriorapplications usingCAD/CAM methods.	Similar; except forthe device tradename and thesubject device hasthe addition of achairsideindication for use.
	Prescription Device	Yes	Yes	Same
DesignCharacteristics	MaterialComposition	The device iscomposed of lithiumaluminosilicate glassmatrix embedded withlithium disilicatecrystals, colorants, andopacifiers to achievethe desired shade.	The device iscomposed of lithiumaluminosilicate glassmatrix embedded withlithium silicatecrystals, colorants, andopacifiers to achievethe desired shade.	Similar; thesubject device ismade of lithiumdisilicate glass,fewer colorants,and opacifiers asopposed to thepredicate device.
	Design	Fully crystallizedlithium disilicate glassceramic available inmilling block form forsingle-unitrestorations.	Partially crystallizedlithium silicate glassceramic available inmilling block form forsingle-unitrestorations.	Similar; thesubject devicedoes not requireadditionalcrystallizationprior to placement.
	Shades	A1, A2, A3, A3.5, B1	A1, A2, A3, A3.5, B1,B2, B3, C1, C2, C3,D2, D3, BL1, and BL4	Similar; no bleachshades and fewerVITA shades areoffered for thesubject device.
Attributes	Subject Device(K234014)	Predicate Device(K141788)	Comparison
Flexural Strength	≥300 MPaType II Class 3 per ISO6872:2015/Amd1:2018	>300 MPaType II Class 3 per ISO6872:2015/Amd1:2018	Same
ChemicalSolubility	<100 µg/cm²	<100 µg/cm²	Same
Biocompatibility	Biocompatible per ISO10993-1	Biocompatible per ISO10993-1	Same
Radioactivity	The activityconcentration ofUranium-238 is nomore than 1.0 Bq/g-1.	The activityconcentration ofUranium-238 is nomore than 1.0 Bq/g-1.	Same
Freedom fromExtraneousMaterials	Shall be free fromextraneous materialswhen assessed byvisual inspection	Shall be free fromextraneous materialswhen assessed byvisual inspection	Same
Glass TransitionTemperature	Shall not deviate bymore than ±20°C	Shall not deviate bymore than ±20°C	Same
Sterility	Non-sterile	Non-sterile	Same

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Image /page/6/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

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Image /page/7/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo features a colorful triangular prism on the left side. To the right of the prism, the text "PRISMATIK DENTALCRAFT, INC." is displayed in a clear, sans-serif font.

Non-Clinical and/or Clinical Tests Summary & Conclusions VII.

Non-clinical data submitted to demonstrate substantial equivalence include:

Flexural Strength according to ISO 6872:2015/Amd 1:2018 .
Visual Shade Evaluation
Color Consistency ●
Cementation Testing ●
Printing & Gluing ●
Uniformity of Color according to ISO 6872:2015/Amd 1:2018
Chemical Solubility according to ISO 6872:2015/Amd 1:2018 ●
Radioactivity according to ISO 6872:2015/Amd 1:2018 ●
Freedom from Extraneous Materials according to ISO 6872:2015/Amd 1:2018
Glass Transition Temperature according to ISO 6872:2015/Amd 1:2018 ●
Biocompatibility assessment per the FDA Guidance "Use of International Standard . ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
Packaging Validation according to ASTM D4169-22 ●

No clinical data is included in this submission.

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Image /page/8/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a gradient of colors, ranging from blue to pink to yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue font.

Flexural Strength

Flexural strength was tested on all shades offered for Obsidian® NOW. The average flexural strength met the acceptance criteria of 300 MPa, which is the value to be achieved for Type II, Class 3 ceramic product according to ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device. Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Visual Shade Evaluation

All shades offered for Obsidian® NOW were evaluated by qualified evaluators using the sample dental restorations milled from the final crystallized products against corresponding VITA® Classical shade guide. Evaluations concluded that Obsidian® NOW meets visual shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Color Consistency

Color consistency within a batch was tested on all shades offered for Obsidian® NOW. A ΔE of less than 2.0 between two coordinates in the CEILAB color space is considered indicative that different samples within a batch being perceptibly identical to one another. Obsidian® NOW meets the color consistency requirement since the ΔE calculation between the samples measured was less than 2.00. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device. Obsidian® NOW, and predicate device. Obsidian Milling Blocks (K141788).

Uniformity of Color

Uniformity of color was tested on all shades offered for Obsidian® NOW to meet the requirement of ISO 6872:2015/Amd 1:2018. Obsidian® NOW meets the uniformity of color requirement since all samples milled into restorations from a representative final finished block were uniform in color when assessed by visual inspection. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Chemical Solubility

The worst cases were tested for solubility and the measured value was <100 µg/cm², meeting the ISO 6872:2015/Amd 1:2018 requirement. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

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Image /page/9/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a color gradient from blue to pink to yellow. To the right of the triangle is the company name, "PRISMATIK DENTALCRAFT, INC." in blue text.

Radioactivity

Obsidian® NOW was tested on the worst cases to meet the radioactivity requirement of ISO 6872:2015/Amd 1:2018. Obsidian® NOW meets the radioactivity requirement since the sample measured below the Uranium-238 activity threshold of 1.0 Bq-g-1 per ISO 6872:2015/Amd 1:2018. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Freedom from Extraneous Materials

All shades offered for Obsidian® NOW were tested to meet the freedom from extraneous materials requirement of ISO 6872:2015/Amd 1:2018. Obsidian® NOW meets the freedom from extraneous materials requirement since the samples were all free from extraneous materials when assessed by visual inspection. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Glass Transition Temperature

All shades offered for Obsidian® NOW were tested to meet the glass transition temperature requirement of ISO 6872:2015/Amd 1:2018. Obsidian® NOW meets the glass transition temperature requirement since the samples did not deviate by more than ±20℃ of the average To obtained across all lots. The results of the testing were used to address questions related to substantial equivalence based on differences in technical specifications between the subject device. Obsidian® NOW, and predicate device. Obsidian Milling Blocks (K141788).

Coefficient of Thermal Expansion (CTE)

Coefficient of thermal expansion was not tested on the subject device, Obsidian® NOW, as it is not applicable. Coefficient of Thermal Expansion (CTE) is an important property if staining and glazing were required, for which the subject device, Obsidian® NOW, is not. This difference in technical specification does not raise any issues related to substantial equivalence between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Block (K141788).

Biocompatibility

Biological evaluation within a risk management process was performed in accordance with ISO 10993-1:2018 and ISO 14971:2019. Based on the cytotoxicity testing results from the subject device, Obsidian® NOW, it was determined that there is no biocompatibility concern regarding dental glass material, colorants, or other elements. The results of the testing were used to address questions related to substantial equivalence based on

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Image /page/10/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a colorful triangle on the left and the company name on the right. The triangle is divided into several sections, each with a different color. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

differences in chemical composition between the subject device, Obsidian® NOW, and predicate device, Obsidian Milling Blocks (K141788).

Packaging Validation

Packaging validation was conducted to ensure that the packaging configurations for Obsidian® NOW are suitable to withstand the distribution environment. Per ASTM D4169-22, Obsidian® NOW was tested to check resistance against manual handling, vehicle stacking, loose load vibration, low pressure (high altitude) hazard, vehicle vibration, and concentrated impact. After the test, the shipping containers were visually inspected for any damage. It was determined that the respective packaging for Obsidian® NOW is suitable for use. The results of the testing were used to address questions related to substantial equivalence based on differences in product packaging between the subject device, Obsidian® NOW, and the predicate device, Obsidian Milling Block (K141788).

VIII. Conclusion

Based on the technological characteristics and non-clinical test data included in this submission, the subject device, Obsidian® NOW, has been shown to be substantially equivalent to the predicate device. Obsidian Milling Block (K141788).

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.