(49 days)
Not Found
No
The summary describes a ceramic material for dental prostheses and its physical properties, with no mention of AI or ML in its function or manufacturing process.
No.
The device is used to fabricate dental prostheses, which are replacements for missing or damaged teeth, rather than directly treating a medical condition or disease.
No
The device is described as ceramic milling blocks used to fabricate dental prostheses (crowns and bridges), not to diagnose a disease or condition. Its performance metrics relate to material properties (e.g., strength, solubility), not diagnostic accuracy.
No
The device description clearly states it is a lithium silicate ceramic block, which is a physical material, not software. The summary focuses on the material properties and performance of the block itself.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Obsidian™ Milling Blocks Function: The Obsidian™ Milling Blocks are used to fabricate dental prostheses (crowns and bridges). This is a manufacturing process for a medical device that will be placed in the body, not a test performed on a sample from the body to diagnose or monitor a condition.
- Intended Use: The intended use clearly states the fabrication of dental prostheses using CAD/CAM methods. There is no mention of analyzing biological samples or providing diagnostic information.
- Device Description: The description focuses on the material properties and how it is used to create dental restorations.
- Performance Studies and Key Metrics: The performance studies and key metrics relate to the physical and chemical properties of the material and its biocompatibility, which are relevant for a dental restorative material, not an IVD.
Therefore, based on the provided information, the Obsidian™ Milling Blocks are a dental restorative material used in the fabrication of dental prostheses, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
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.
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
Not Found
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)
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.
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:
- 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 subject.
- The Irritation Report shows that there was no erythema or edema on the test subject.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Flexural Strength: >300 MPa (meeting ISO 6872 requirements)
Chemical Solubility:
§ 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
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.
1
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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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) 225-1234 |
| Senior RA Specialist | |
| Secondary Contact Person | Marilyn Pourazar, (949) 225-1269 |
| 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
Obsidian Ceramic Blocks
510(k)-K100781 | Proposed Device
Obsidian Milling Blocks | Similarities and
Difference
Between the
Predicate
and the Proposed
Device |
|------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|
| Indications for Use | This device is used to fabricate
ceramic dental prostheses in the
nature of crowns and bridges for
posterior and anterior applications
using CAD/CAM or hot-press
methods. | This device is used to fabricate
ceramic dental prostheses in the
nature of crowns and bridges
for posterior and anterior
applications using CAD/CAM
methods. | Same |
| Composition | The average composition of the
proposed device is provided. Refer
to section 011. | The average composition of the
proposed device is provided
Refer to section 011. | Additional materials were
added. 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 6872
requirements) | >300 MPa (meeting ISO
6872 requirements) | Same |
| Chemical Solubility |