OBSIDIAN MILLING BLOCKS

K141788 · Prismatik Dentalcraft, Inc. · EIH · Aug 20, 2014 · Dental

Device Facts

• Record ID: K141788
• Device Name: OBSIDIAN MILLING BLOCKS
• Applicant: Prismatik Dentalcraft, Inc.
• Product Code: EIH · Dental
• Decision Date: Aug 20, 2014
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.

Device Story

Obsidian™ Milling Blocks are lithium silicate ceramic blocks, supplied with or without an attached mandrel, designed for fabrication of monolithic dental restorations (crowns, inlays, onlays, veneers, partial crowns, substructures). Used in dental clinics/laboratories; operated by dental professionals using CAD/CAM milling systems. Blocks are milled into final prosthetic shapes to provide esthetic, translucent, and high-strength restorations. Device benefits include restoration of dental function and esthetics. No software or electronic components integral to the block itself; milling process relies on external CAD/CAM hardware/software.

Clinical Evidence

Bench testing only. Performance verified against ISO 6872 standards for flexural strength, chemical solubility, radioactivity, and thermal expansion. Biocompatibility testing performed per ISO 10993-5 (cytotoxicity) and ISO 10993-10 (sensitization and irritation), with all tests resulting in a 'Pass'.

Technological Characteristics

Lithium silicate ceramic material. Form factor: milling blocks (with/without mandrel). Standards: ISO 6872 (flexural strength, solubility, radioactivity, thermal expansion), ISO 10993-5/10 (biocompatibility). Energy source: N/A (mechanical milling). Connectivity: N/A. Sterilization: Not specified.

Indications for Use

Indicated for fabrication of ceramic dental prostheses (crowns and bridges) for posterior and anterior applications in patients requiring dental restoration.

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

• Obsidian™ Ceramic Blocks (K100781)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 20, 2014

Prismatik Dentalcraft, Incorporated Mr. Armin Zehtabchi Senior RA Specialist 2212 Dupont Drive, Suite IJK Irvine California 92612

Re: K141788

Trade/Device Name: Obsidian™ Milling Blocks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: July 22, 2014 Received: July 23, 2014

Dear Mr. Zehtabchi:

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. 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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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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Mary S. Runner -ഗ

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Device Evaluation Center for Devices and Radiological Health

Enclosure

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES |
|-----------------------------------------|
| Food and Drug Administration |

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) TBD

41788

Device Name

Obsidian™ Milling Blocks

Indications for Use (Describe)

The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.

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)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

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K 141788
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Image /page/3/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the company name on the right. The triangle is divided into smaller triangles, creating a prism-like effect. The text is in a simple, sans-serif font.

B.

## 007_510 (K) Summary-807.92(c)

This 510 (k) summary is being submitted in accordance with the requirements of SMDA of 1990 and 21 CFR 807.92.

#### SUBMITTER INFORMATION A.

| Company Name: | Prismatik Dentalcraft, Inc. |
|-------------------------------|------------------------------------------------------------|
| Company Address: | 2212 Dupont Dr., Suite IJK,<br>Irvine, CA 92612 |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, [phone]<br>Senior RA Specialist |
| Secondary Contact Person | Marilyn Pourazar, [phone]<br>Senior Director, RA/QA |
| Date Summary Prepared: | July 1, 2014 |
| Trade/Proprietary Name: | Obsidian™ Milling Blocks |
| 21 CFR Reference: | 21 CFR 872.6660 |
| 21 CFR Common Name: | Porcelain powder for clinical use |
| Classification: | Class II, EIH |
| Panel: | Dental |

### C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

Obsidian™ Ceramic Blocks-K100781

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Image /page/4/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the text "PRISMATIK DENTALCRAFT, INC." on the right. The triangle is divided into three sections, each with a different pattern.

#### D. PROPOSED DEVICE DESCRIPTION

The Obsidian™ Milling Blocks are a lithium silicate ceramic to be supplied with or without an attached mandrel to be milled using CAD/CAM methods. The product can produce a variety of monolithic restorations with great esthetics, lifelike translucency, and high strength including full-contour crowns, inlays, onlays, veneers partial crowns and substructures due to its excellent machining properties. The milling blocks will be available in the commonly used VITA Classical and Chromascop Bleach shades.

#### E. INDICATIONS FOR USE

The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.

#### F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The comparison table below outlines and provides the similarities and the substantial-equivalency of the predicate-Obsidian™ Ceramic-Blocks-K100781-(cleared by Prismatik Dentalcraft, Inc. on 6/21/2010) and the proposed Obsidian™ Milling Blocks, and Prismatik believes that the comparative data presented in the preceding paragraphs, demonstrate that proposed Obsidian™ Milling Blocks is essentially the same as currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of porcelain powder for clinical use (21 CFR 872.6660) that have previously been found to be substantially equivalent. and that any differences between the proposed device Obsidian™ Milling Blocks and the predicate device do not introduce any new issues of safety or effectiveness. Both the proposed device and the predicate device consist of general glass ceramic material and have the same intended use.

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Image /page/5/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of the company name in a simple, sans-serif font. To the left of the text is a geometric shape that resembles a prism, which is likely a visual representation of the company's name. The overall design is clean and professional, suggesting a focus on precision and quality.

| Attributes | Predicate Device<br>Obsidian Ceramic Blocks<br>510(k)-K100781 | Proposed Device<br>Obsidian Milling Blocks | Similarities and<br>Difference<br>Between the<br>Predicate<br>and the Proposed<br>Device |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for Use | This device is used to fabricate<br>ceramic dental prostheses in the<br>nature of crowns and bridges for<br>posterior and anterior applications<br>using CAD/CAM or hot-press<br>methods. | This device is used to fabricate<br>ceramic dental prostheses in the<br>nature of crowns and bridges<br>for posterior and anterior<br>applications using CAD/CAM<br>methods. | Same |
| Composition | The average composition of the<br>proposed device is provided. Refer<br>to section 011. | The average composition of the<br>proposed device is provided<br>Refer to section 011. | Additional materials were<br>added. Refer to section 011. |
| Shades | A1, A2, A3, A35, B1, B2, B3, C1,<br>C2, C3, D2, D3, BL1 and BL4 | A1, A2, A3, A35, B1, B2, B3,<br>C1, C2, D2, D3, BL1 and BL4 | Same |
| Flexural Strength | >300 MPa (meeting ISO 6872<br>requirements) | >300 MPa (meeting ISO<br>6872 requirements) | Same |
| Chemical Solubility | < 100µg/cm² (meeting ISO 6872<br>requirements) | < 100µg/cm² (meeting ISO<br>6872 requirements) | Same |
| Freedom from<br>Extraneous Material | Shall be free from extraneous<br>materials when assessed by visual<br>inspection (meeting ISO 6872<br>requirements) | Shall be free from extraneous<br>materials when assessed by<br>visual inspection (meeting ISO<br>6872 requirements) | Same |
| Radioactivity | Activity concentration of uranium238<br>less than 1.0Bq g-1 (meeting ISO<br>6872 requirements) | Activity concentration of<br>uranium238 less than 1.0Bq g-1<br>(meeting ISO 6872<br>requirements) | Same |
| Coefficient of Thermal<br>Expansion (25-500°C) | 12.2+/-0.5 x10-6 °C (meeting ISO<br>6872 requirements) | 12.2+/-0.5 x 10-6 °C (meeting<br>ISO 6872 requirements) | Same |
| Packaging | Boxes of 5 blocks for Milling<br>Blocks | Boxes of 5 blocks for Milling<br>Blocks | Same |
| Biocompatibility | Non-toxic and biocompatible<br>(Meeting the ISO 10993-5 and<br>10993-10 Requirements) | Non-toxic and biocompatible<br>(Meeting the ISO 10993-5 and<br>10993-10 Requirements) | Same |
| Accessories | Veneering/Add-On Powders, Paste<br>Stains and Glaze, Low Fusing | Veneering/Add-On Powders,<br>Paste Stains and Glaze, Low | Same |

# Table 1 - Comparison between Predicate and Proposed Device

#### G. SUMMARY OF NON-CLINICAL TESTING

To meet the ISO 6872 requirements, various non-clinical and applicable tests were performed in accordance with the Design Verification Plan including a Risk Analysis addressing the impact of changes to the device. The test results for the Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, and Coefficient Thermal Expansion indicate the Obsidian™ Milling Blocks is comparable to the predicate device.

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Image /page/6/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the company name on the right. The triangle is filled with a pattern of lines and shapes. The company name is written in a sans-serif font.

In addition, the proposed device, Obsidian™ Milling Blocks, have been tested for Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10) to meet the biocompatibility requirement and the reports are as follow:

- 0 The Cytotoxicity Report shows that there was no reaction on any of the cells.
- The Sensitization Report shows that there was no reaction on the tested o subject.
- The Irritation Report shows that there was no erythema or edema on the test o subject.

| Test Description | Results |
|------------------------------------------------------------------------------------------------------|---------|
| Cytotoxicity Study using the IX MEM extraction method at 37°C | Pass |
| ISO Intracutaneous Study, Extract 0.9% sodium chloride USP solution<br>(SC) and sesame oil, NF (SO) | Pass |
| Irritation and Skin Sensitization Study, Extract 0.9% sodium chloride<br>USP and sesame oil, NF (SO) | Pass |

Copies of the tests results are attached. Refer to Attachment A.

#### H. CONCLUSION

The proposed device, Obsidian™ Milling Blocks has the same performance specifications, fundamental scientific technology and intended use as that of the predicate device, Obsidian™ Ceramic Blocks. The changes to the device do not raise any new questions regarding safety or efficacy. The performance data and a declaration of conformity with design controls support a determination of continuing substantial equivalence of the proposed device to the predicate device.