(70 days)
Not Found
No
The summary describes a ceramic block for dental restorations and its physical properties and testing, with no mention of AI or ML.
No
This device is a material (lithium disilicate glass-ceramic block) used to fabricate dental prostheses, not a therapeutic device that directly treats or prevents a disease or condition.
No
This device is a material (lithium disilicate glass-ceramic block) used to fabricate dental prostheses, not a device that performs diagnostic functions. Its purpose is to create restorations, not to diagnose conditions.
No
The device description clearly states it is a "fully crystallized lithium disilicate glass-ceramic block" and the performance studies focus on material properties and physical testing, indicating it is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology." This describes a device used to create a physical medical device (a dental crown) for direct use on a patient.
- Device Description: The description details a "fully crystallized lithium disilicate glass-ceramic block" used for milling dental restorations. This is a material used in the manufacturing process of a medical device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test a sample from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used to create a dental prosthesis, which is a therapeutic device.
N/A
Intended Use / Indications for Use
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.
Product codes
EIH
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.
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
dental laboratories or by dental professionals.
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)
Non-clinical data submitted to demonstrate substantial equivalence include:
- Flexural Strength according to ISO 6872:2015/Amd 1:2018 . 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.
- Visual Shade Evaluation. Evaluations concluded that Obsidian® NOW meets visual shade match requirements and works as intended.
- Color Consistency. Obsidian® NOW meets the color consistency requirement since the ΔE calculation between the samples measured was less than 2.00.
- Cementation Testing
- Printing & Gluing
- Uniformity of Color according to 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.
- Chemical Solubility according to ISO 6872:2015/Amd 1:2018. The measured value was
§ 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/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.
1
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).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
Obsidian® NOW
Indications for Use (Describe)
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.
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
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.
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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
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.
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 Milling
Block | 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 is
intended to be used in
fabrication of dental
restorations for the
purpose of restoring
chewing function. | Obsidian Milling
Block is intended to be
used in fabrication of
dental restorations for
the purpose of
restoring chewing
function. | Same; except for
the device trade
name. |
| | Indications for Use | 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. | The Obsidian Milling
Blocks are used to
fabricate ceramic
dental prostheses in
the nature of crowns
and bridges for
posterior and anterior
applications using
CAD/CAM methods. | Similar; except for
the device trade
name and the
subject device has
the addition of a
chairside
indication for use. |
| | Prescription Device | Yes | Yes | Same |
| Design
Characteristics | Material
Composition | The device is
composed of lithium
aluminosilicate glass
matrix embedded with
lithium disilicate
crystals, colorants, and
opacifiers to achieve
the desired shade. | The device is
composed of lithium
aluminosilicate glass
matrix embedded with
lithium silicate
crystals, colorants, and
opacifiers to achieve
the desired shade. | Similar; the
subject device is
made of lithium
disilicate glass,
fewer colorants,
and opacifiers as
opposed to the
predicate device. |
| | Design | Fully crystallized
lithium disilicate glass
ceramic available in
milling block form for
single-unit
restorations. | Partially crystallized
lithium silicate glass
ceramic available in
milling block form for
single-unit
restorations. | Similar; the
subject device
does not require
additional
crystallization
prior 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 bleach
shades and fewer
VITA shades are
offered for the
subject device. |
| Attributes | Subject Device
(K234014) | Predicate Device
(K141788) | Comparison | |
| Flexural Strength | ≥300 MPa
Type II Class 3 per ISO
6872:2015/Amd
1:2018 | >300 MPa
Type II Class 3 per ISO
6872:2015/Amd
1:2018 | Same | |
| Chemical
Solubility |