(115 days)
Not Found
No
The device description focuses on the material properties and fabrication method of a dental ceramic, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a ceramic material used to fabricate dental prostheses like crowns and bridges, which are restorative, not therapeutic, devices.
No
The device is a ceramic material used to fabricate dental prostheses, not to diagnose a condition or disease.
No
The device description clearly states that the device is a lithium silicate ceramic supplied in the form of ingots, which are physical materials, 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 dental prostheses (crowns, bridges, veneers, inlays, onlays). This is a restorative and structural application within the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a ceramic material in the form of ingots used for pressing into dental restorations. This is a material used for manufacturing a medical device, not a diagnostic reagent or instrument.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a disease, condition, or state of health. It is purely a material for creating a physical restoration.
- Performance Studies: The performance studies focus on material properties (flexural strength, chemical solubility, etc.) and biocompatibility, which are relevant for a dental material intended for implantation, not for diagnostic accuracy.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Obsidian™ Press is a lithium silicate ceramic to be supplied in the form of ingots to be pressed to temperature in various furnaces. The increased Obsidian™ Press CTE value is intended to allow the Obsidian™ Press ceramic to be used in Press Over Metal applications, using various approved dental alloys, in addition to the all ceramic applications. The ingots are designed to be pressed into a variety of restorations including Press Over Metal (POM) such as full contour crowns and bridges, as well as monolithic all-ceramic restorations such as full contour crowns, up to 3-unit anterior bridges (including pre-molar region as terminal abutment), inlays, onlays, partial crowns, and veneers with esthetics, translucency, and strength. The ingots 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. The test results for Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, and Coefficient Thermal Expansion indicate that Obsidian™ Press (All Ceramic and POM) is comparable to the predicate devices.
Additionally, Obsidian™ Press (All-Ceramic and POM) has been tested for Biocompatibility (Cytotoxicity (ISO 10993-5), Sensitization (ISO 10993-10), and Irritation (ISO 10993-10)).
- 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.
Summary of results for biocompatibility tests:
- 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 chloride USP and sesame oil, NF (SO): Pass
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of three faces in profile, stacked on top of each other. The faces are stylized and appear to be moving forward.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 6,2014
Prismatik DentalCraft, Inc. Armin Zehtabchi Senior RA Specialist 2212 Dupont Drive. Suite P Irvine California 92612
Re: K141887
Trade/Device Name: Obsidian TM Press (All Ceramic and POM) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: August 26, 2014 Received: September 29, 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.
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
1
Page 2 - Mr. Zehtabchi
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.
Susan Runno DDS, mA
Erin I. Keith, M.S Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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Form Approved: OMB No. 0910-0120
Expiration Date: January 31, 2017
See PRA Statement below.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K141887
Device Name ObsidianTM Press (All-Ceramic and POM)
Indications for Use (Describe)
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, veneers, inlays, and onlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing 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."
3
B.
006-510 (K) Summary-807.92(c)
This 510 (k) summary is being submitted in accordance with the requirements of SMDA and 21 CFR 807.92.
A. SUBMITTER INFORMATION
| Company Name: | Prismatik Dentalcraft, Inc. |
|---|---|
| Company Address: | 2212 Dupont Dr., Suite P, |
| 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: | November 5, 2014 |
| DEVICE IDENTIFICATION | |
| Trade/Proprietary Name: | Obsidian™ Press (All-Ceramic and POM) |
| 21 CFR Reference: | 21 CFR 872.6660 |
| 21 CFR Common Name: | Porcelain powder for clinical use |
| Classification: | Class II, EIH |
| Panel: | Dental |
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Image /page/4/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangular prism with a color gradient on the left side. The text "PRISMATIK DENTALCRAFT, INC." is located to the right of the prism.
C. IDENTIFICATION OF PREDICATE DEVICE
Trade/Proprietary Name:
- Obsidian™ Ceramic Blocks-K100781 ●
- IPS e.max Press and IPS e.max Press Multi (Ivoclar Vivadent, Incorporated)-K120134
- IPS 99 One and IPS 99 Ceram ● (Ivoclar Vivadent, Incorporated)-510(k)-K121359
D. DEVICE DESCRIPTION
Obsidian™ Press is a lithium silicate ceramic to be supplied in the form of ingots to be pressed to temperature in various furnaces. The increased Obsidian™ Press CTE value is intended to allow the Obsidian™ Press ceramic to be used in Press Over Metal applications, using various approved dental alloys, in addition to the all ceramic applications. The ingots are designed to be pressed into a variety of restorations including Press Over Metal (POM) such as full contour crowns and bridges, as well as monolithic all-ceramic restorations such as full contour crowns, up to 3-unit anterior bridges (including pre-molar region as terminal abutment), inlays, onlays, partial crowns, and veneers with esthetics, translucency, and strength. The ingots will be available in the commonly used VITA Classical and Chromascop Bleach shades.
E. INDICATIONS FOR USE
The Obsidian™ Press ceramic is used to fabricate Press Over Metal dental prostheses in the nature of crowns and bridges as well as monolithic dental prostheses in the nature of crowns, partial crowns, veneers, inlays for posterior and anterior applications, as well as 3-unit anterior bridges (including pre-molar region as terminal abutment) using pressing methods.
F. DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The comparison table below outlines and provides the similarities and the substantial equivalency of the predicate devices, Obsidian™ Ceramic Blocks, 510(k)-K100781, IPS e.max Press and IPS e.max Press Multi (Ivoclar Vivadent, Incorporated), 510(k)-K120134, IPS 99 One and IPS 99 Ceram (Ivoclar Vivadent, Incorporated), 510(k)-K121359 and the proposed device, Obsidian™ Press (All-Ceramic and POM), and Prismatik believes that the comparative data presented in the preceding paragraphs, demonstrate that Obsidian™ Press (All-Ceramic and POM) is essentially the same as currently marketed devices for the same indication 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™ Press (All-Ceramic and POM) and the predicate device do not introduce any new issues of safety or effectiveness.
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Image /page/5/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.
| Attributes | Predicate Devices | | IPS 99 One and IPS
99 Ceram
(Vivadent,
Incorporated)
510(k)-K121359 | Proposed Device | Similarities
and
Differences
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. | IPS e.max Press
and IPS e.max
Press Multi (Ivoclar
Vivadent,
Incorporated)
510(k)K120134 | IPS 99 One is a
one-layer
veneering ceramic
for the fabrication
of metal-ceramic
restorations using
the most popular
dental alloys in the
CTE range of 13.8-
15.0 x 10-6/K (25-
500°C)
IPS 99 Ceram is a
conventional multi-
layer veneering
ceramic for the
fabrication of metal
ceramic
restorations using
the most popular
dental alloys in the
range of 13.8-15.0
x 10-6/K (25-
500°C).
IPS 99 is intended
to be used for
inlays, onlays,
veneers, and
anterior/posterior
PFM crowns. | The Obsidian™
Press ceramic is
used to fabricate
Press Over Metal
dental prostheses in
the nature of crowns
and bridges as well
as monolithic dental
prostheses in the
nature of crowns,
partial crowns,
veneers, inlays, and
onlays for posterior
and anterior
applications, as
well as 3-unit
anterior bridges
(including pre-molar
region as terminal
abutment) using
pressing methods. | Substantially
equivalent |
| Shades | A1, A2, A3, A35,
B1, B2, B3, C1,
C2, C3, D2, D3,
BL1 and BL4 | High and low
translucencies): 16
A-D and 4 Bleach
BL shades | A1, A2, A3, A35,
B1, B2, B3, C1,
C2, 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) | >300 MPa
(meeting ISO 6872
requirements) | >300 MPa
(meeting ISO 6872
requirements) | Same |
| Chemical
Solubility |