(49 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information for the Obsidian™ Milling Blocks, based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Predicate) | Reported Device Performance (Proposed Device) | Substantial Equivalence |
|---|---|---|
| Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM or hot-press methods. | Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM methods. | Same (Proposed explicitly states CAD/CAM, but overall use is consistent) |
| Composition: Provided in Section 011 (though not detailed in the comparison table) | Composition: Provided in Section 011. Additional materials were added (details in section 011). | Difference (Additional materials were added, but deemed not to introduce new safety/effectiveness issues) |
| Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1, BL4 | Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1, BL4 | Same |
| Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Flexural Strength: >300 MPa (meeting ISO 6872 requirements) | Same |
| Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements) | Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements) | Same |
| Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) | Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements) | Same |
| Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) | Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements) | Same |
| Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x10-6 °C (meeting ISO 6872 requirements) | Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x 10-6 °C (meeting ISO 6872 requirements) | Same |
| Packaging: Boxes of 5 blocks for Milling Blocks | Packaging: Boxes of 5 blocks for Milling Blocks | Same |
| Biocompatibility: Non-toxic and biocompatible (Meeting ISO 10993-5 and 10993-10 Requirements) - No reaction on cells (Cytotoxicity) - No reaction on tested subject (Sensitization) - No erythema or edema on test subject (Irritation) | Biocompatibility: Non-toxic and biocompatible (Meeting ISO 10993-5 and 10993-10 Requirements) - Cytotoxicity Study: Pass - ISO Intracutaneous Study: Pass - Irritation and Skin Sensitization Study: Pass | Same (Passes all tests) |
2. Sample size used for the test set and the data provenance
The document does not specify the exact sample sizes used for each individual non-clinical test (e.g., number of blocks for flexural strength, number of samples for chemical solubility, etc.). It generally refers to "test results" meeting ISO requirements.
For biocompatibility, it mentions "tested subject" for sensitization and irritation reports, implying animal testing, but the number of subjects and their origin are not provided.
The provenance of data is not explicitly stated. The tests were performed "in accordance with the Design Verification Plan," suggesting internal testing or testing by contract labs.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided in the document. The tests performed are objective, quantitative measurements against established ISO standards and do not involve expert interpretation or ground truth establishment in a clinical sense.
4. Adjudication method for the test set
This information is not applicable and not provided. The tests are based on objective measurements and comparison to predefined acceptance criteria within ISO standards.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a dental material, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a dental material, not an algorithm or AI system.
7. The type of ground truth used
The "ground truth" used for device acceptance is based on:
- Established ISO Standards: Specifically ISO 6872 for flexural strength, chemical solubility, freedom from extraneous material, radioactivity, and coefficient of thermal expansion.
- Biocompatibility Standards: ISO 10993-5 (Cytotoxicity) and ISO 10993-10 (Sensitization and Irritation).
- Comparison to Predicate Device: The performance of the proposed device is compared directly to the cleared predicate device, Obsidian™ Ceramic Blocks (K100781), demonstrating "essentially the same" performance for the relevant physical and chemical properties and biocompatibility.
8. The sample size for the training set
This is not applicable. This document describes a medical device (milling blocks), not a machine learning or AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable, as there is no training set for this device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three human profiles incorporated into its design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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:
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K 141788
Page 10 of 32
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,Irvine, CA 92612 |
| Company Phone: | 949-225-1269 |
| Company FAX: | 949-553-0924 |
| Facility Registration Number: | 3005477956 |
| Primary Contact Person: | Armin Zehtabchi, (949) 225-1234Senior RA Specialist |
| Secondary Contact Person | Marilyn Pourazar, (949) 225-1269Senior 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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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 DeviceObsidian Ceramic Blocks510(k)-K100781 | Proposed DeviceObsidian Milling Blocks | Similarities andDifferenceBetween thePredicateand the ProposedDevice |
|---|---|---|---|
| Indications for Use | This device is used to fabricateceramic dental prostheses in thenature of crowns and bridges forposterior and anterior applicationsusing CAD/CAM or hot-pressmethods. | This device is used to fabricateceramic dental prostheses in thenature of crowns and bridgesfor posterior and anteriorapplications using CAD/CAMmethods. | Same |
| Composition | The average composition of theproposed device is provided. Referto section 011. | The average composition of theproposed device is providedRefer to section 011. | Additional materials wereadded. Refer to section 011. |
| Shades | A1, A2, A3, A35, B1, B2, B3, C1,C2, C3, D2, D3, BL1 and BL4 | A1, A2, A3, A35, B1, B2, B3,C1, C2, D2, D3, BL1 and BL4 | Same |
| Flexural Strength | >300 MPa (meeting ISO 6872requirements) | >300 MPa (meeting ISO6872 requirements) | Same |
| Chemical Solubility | < 100µg/cm² (meeting ISO 6872requirements) | < 100µg/cm² (meeting ISO6872 requirements) | Same |
| Freedom fromExtraneous Material | Shall be free from extraneousmaterials when assessed by visualinspection (meeting ISO 6872requirements) | Shall be free from extraneousmaterials when assessed byvisual inspection (meeting ISO6872 requirements) | Same |
| Radioactivity | Activity concentration of uranium238less than 1.0Bq g-1 (meeting ISO6872 requirements) | Activity concentration ofuranium238 less than 1.0Bq g-1(meeting ISO 6872requirements) | Same |
| Coefficient of ThermalExpansion (25-500°C) | 12.2+/-0.5 x10-6 °C (meeting ISO6872 requirements) | 12.2+/-0.5 x 10-6 °C (meetingISO 6872 requirements) | Same |
| Packaging | Boxes of 5 blocks for MillingBlocks | Boxes of 5 blocks for MillingBlocks | Same |
| Biocompatibility | Non-toxic and biocompatible(Meeting the ISO 10993-5 and10993-10 Requirements) | Non-toxic and biocompatible(Meeting the ISO 10993-5 and10993-10 Requirements) | Same |
| Accessories | Veneering/Add-On Powders, PasteStains and Glaze, Low Fusing | Veneering/Add-On Powders,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(SC) and sesame oil, NF (SO) | Pass |
| Irritation and Skin Sensitization Study, Extract 0.9% sodium chlorideUSP 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.
§ 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.