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.

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.

AI/ML Overview

Here's an analysis of the provided text to extract information regarding acceptance criteria and the supporting study, formatted as requested:

Device Name: Obsidian™ Press (All-Ceramic and POM)

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Predicate Devices & Proposed Device)	Reported Device Performance (Obsidian™ Press)
Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1 and BL4 (for Obsidian™ Ceramic Blocks and IPS 99 One/Ceram) Or High and low translucencies: 16 A-D and 4 Bleach BL shades (for IPS e.max Press)	A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1 and BL4
Flexural Strength: >300 MPa (meeting ISO 6872 requirements)	>300 MPa (meeting ISO 6872 requirements)
Chemical Solubility: < 100µg/cm² (meeting ISO 6872 requirements)	< 100µg/cm² (meeting ISO 6872 requirements)
Freedom from Extraneous Material: Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements)	Shall be free from extraneous materials when assessed by visual inspection (meeting ISO 6872 requirements)
Radioactivity: Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements)	Activity concentration of uranium238 less than 1.0Bq g-1 (meeting ISO 6872 requirements)
Coefficient of Thermal Expansion (25-500°C): 12.2+/-0.5 x10-6 °C (meeting ISO 6872 requirements)	12.2+/-0.5 x 10-6 °C (meeting ISO 6872 requirements)
Biocompatibility: Non-toxic and biocompatible (Meeting the ISO 10993-5 and 10993-10 Requirements)	Non-toxic and biocompatible (Meeting the ISO 10993-5 and 10993-10 Requirements)
Cytotoxicity Study: Pass (using the IX MEM extraction method at 37°C)	Pass (no reaction on any of the cells)
ISO Intracutaneous Study: Pass (Extract 0.9% sodium chloride USP solution and sesame oil, NF)	Pass (no reaction on the tested subject)
Irritation and Skin Sensitization Study: Pass (Extract 0.9% sodium chloride USP and sesame oil, NF)	Pass (no erythema or edema on the test subject)

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document mentions "various non-clinical and applicable tests were performed" and then lists specific performance and biocompatibility tests. However, it does not specify the sample sizes used for these tests. It also does not provide information on the country of origin of the data or whether the studies were retrospective or prospective. The information implies these were lab-based tests conducted to meet ISO standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This report focuses on non-clinical, material science, and biocompatibility testing. Therefore, it does not involve experts establishing ground truth in the context of diagnostic performance (e.g., radiologists). The "ground truth" for these tests would be defined by the standardized testing methodologies themselves (e.g., ISO 6872 requirements for flexural strength, ISO 10993 for biocompatibility) and the results obtained from those methodologies.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

Not applicable. Adjudication methods are typically relevant for studies where human interpretation or consensus is required to establish ground truth, often in diagnostic imaging or clinical trials. This submission involves laboratory-based material testing and biocompatibility studies, where the results are quantitative or based on defined pass/fail criteria according to international 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

Not applicable. This device is a dental material (lithium silicate ceramic), not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant to this submission.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

Not applicable. This product is a physical dental material, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the performance criteria listed (Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, Coefficient of Thermal Expansion) is established by conformance to established international standards (ISO 6872).

For biocompatibility (Cytotoxicity, Sensitization, Irritation), the ground truth is established by conformance to ISO 10993 standards and the observed biological responses (e.g., no reaction on cells, no erythema/edema).

8. The sample size for the training set

Not applicable. This submission is for a physical device (dental ceramic), not a machine learning model that requires a training set. The "testing" involves physical and biological assessment of the material itself.

9. How the ground truth for the training set was established

Not applicable. As the device is not an AI/ML product, there is no training set or associated ground truth for such a purpose.

Summary

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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

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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)

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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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) 225-1234Senior RA Specialist
Secondary Contact Person	Marilyn Pourazar, (949) 225-1269Senior 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

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 IPS99 Ceram(Vivadent,Incorporated)510(k)-K121359	Proposed Device	SimilaritiesandDifferencesBetween thePredicateand theProposedDevice
Indications forUse	This device is usedto fabricateceramic dentalprostheses in thenature of crownsand bridges forposterior andanteriorapplications usingCAD/CAM or hot-press methods.	IPS e.max Pressand IPS e.maxPress Multi (IvoclarVivadent,Incorporated)510(k)K120134	IPS 99 One is aone-layerveneering ceramicfor the fabricationof metal-ceramicrestorations usingthe most populardental alloys in theCTE range of 13.8-15.0 x 10-6/K (25-500°C)IPS 99 Ceram is aconventional multi-layer veneeringceramic for thefabrication of metalceramicrestorations usingthe most populardental alloys in therange of 13.8-15.0x 10-6/K (25-500°C).IPS 99 is intendedto be used forinlays, onlays,veneers, andanterior/posteriorPFM crowns.	The Obsidian™Press ceramic isused to fabricatePress Over Metaldental prostheses inthe nature of crownsand bridges as wellas monolithic dentalprostheses in thenature of crowns,partial crowns,veneers, inlays, andonlays for posteriorand anteriorapplications, aswell as 3-unitanterior bridges(including pre-molarregion as terminalabutment) usingpressing methods.	Substantiallyequivalent
Shades	A1, A2, A3, A35,B1, B2, B3, C1,C2, C3, D2, D3,BL1 and BL4	High and lowtranslucencies): 16A-D and 4 BleachBL shades	A1, A2, A3, A35,B1, B2, B3, C1,C2, D2, D3, BL1and BL4	A1, A2, A3, A35,B1, B2, B3, C1, C2,D2, D3, BL1 andBL4	Same
Flexural Strength	>300 MPa(meeting ISO 6872requirements)	>300 MPa(meeting ISO 6872requirements)	>300 MPa(meeting ISO 6872requirements)	>300 MPa(meeting ISO 6872requirements)	Same
ChemicalSolubility	< 100µg/cm²(meeting ISO 6872requirements)	< 100µg/cm²(meeting ISO 6872requirements)	< 100µg/cm²(meeting ISO 6872requirements)	< 100µg/cm²(meeting ISO 6872requirements)	Same
	Predicate Devices			Proposed Device	Similaritiesand
Attributes	Obsidian™ CeramicBlocks510(k)-K100781	IPS e.max Press andIPS e.max PressMulti (IvoclarVivadent.Incorporated)510(k)-K120134	IPS 99 One and IPS99 Ceram(Vivadent,Incorporated)510(k)-K121359	Obsidian™ Press (AllCeramic and POM)	DifferencesBetween thePredicateand theProposedDevice
Freedom fromExtraneousMaterial	Shall be free fromextraneousmaterials whenassessed by visualinspection (meetingISO 6872requirements)	Shall be free fromextraneousmaterials whenassessed by visualinspection (meetingISO 6872requirements)	Shall be free fromextraneousmaterials whenassessed by visualinspection (meetingISO 6872requirements)	Shall be free fromextraneous materialswhen assessed byvisual inspection(meeting ISO 6872requirements )	Same
Radioactivity	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Activityconcentration ofuranium238 less than1.0Bq g-1 (meetingISO 6872requirements)	Same
Coefficient ofThermalExpansion(25-500°C)	12.2+/-0.5 x10-6 °C(meeting ISO 6872requirements)	12.2+/-0.5 x10-6 °C(meeting ISO 6872requirements)	12.2+/-0.5 x10-6 °C(meeting ISO 6872requirements)	12.2+/-0.5 x 10-6 °C(meeting ISO 6872requirements)	Same
Biocompatibility	Non-toxic andbiocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-5 and 10993-10 Requirements)	Same

Table 1 – Comparison between Predicate and Proposed Device

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Image /page/6/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 made up of different colors, including pink, blue, and green. The company name is written in blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.

SUMMARY OF NON-CLINICAL TESTING/PERFORMANCE DATA G.

To meet the ISO 6872 requirements, various non-clinical and applicable tests were performed, and the tests results for the Flexural Strength, Chemical Solubility, Freedom from Extraneous Material, Radioactivity, and Coefficient Thermal Expansion indicate the Obsidian™ Press (All Ceramic and POM) is comparable to the predicate devices.

In addition, the Obsidian™ Press (All-Ceramic and POM) has 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.

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Image /page/7/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangular shape with a rainbow gradient, with colors ranging from blue to pink. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is colored in a dark blue.

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 chloride USPand sesame oil, NF (SO)	Pass

A copy of the tests result is provided in the Attachment A.

H. CONCLUSION FROM THE NON-CLINICAL TESTING/ PERFORMANCE DATA

The proposed Obsidian™ Press (All-Ceramic and POM) has the same performance specifications, fundamental scientific technology and intended use as that 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 and IPS 99 One and IPS 99 Ceram (Ivoclar Vivadent, Incorporated), 510(k)-K121359. These devices are substantially equivalent, and that any differences between the Obsidian™ Press (All-Ceramic and POM) and the cited predicate devices do not introduce any new issues of safety or effectiveness.

Regulation Number and Section

§ 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.