IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through CAD-CAM techniques for the fabrication of: Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and veneers. IRIS can be used as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.

Device Description

IRIS - High Strength Glass Ceramic is a system of glass ceramic dental materials based on zirconia reinforced lithium silicate chemistries and feldspathic veneering ceramics and accessories optimized to be compatible with IRIS glass ceramics. The system consists of: A. IRIS Flex: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the fully crystallized state, for machining and subsequent placement. B. IRIS CAD: High Strength Glass Ceramic (HSGC) CAD CAM blanks provided in the partially crystallized state, for machining, crystallization firing, and subsequent placement. C. Veneering ceramics provided in powder/paste forms and are intended for optional esthetic characterization of the CAD CAM restorations. IRIS materials may be veneered with a compatible dental veneering ceramic or can be used as anatomically shaped full-contour restorations without veneering.

AI/ML Overview

The provided text describes the "IRIS - High Strength Glass Ceramic" device and its substantial equivalence to a predicate device, rather than a clinical study evaluating its performance against specific acceptance criteria. Therefore, several requested sections of the response, such as sample sizes, expert qualifications, and adjudication methods, cannot be directly extracted as they relate to clinical effectiveness studies, which were explicitly stated as "Not applicable. No human clinical testing was conducted to support the substantial equivalence of the IRIS - High Strength Glass Ceramic."

However, the document does detail material properties testing, which serves as the "study" proving the device meets material-related acceptance criteria.

Here's the information that can be extracted and a clear indication of what is not applicable based on the provided text:

Acceptance Criteria and Device Performance

The acceptance criteria for the IRIS - High Strength Glass Ceramic are primarily based on ISO 6872 standards and comparability to the predicate device, IPS e.max CAD (K051705). The reported performance indicates the device meets these criteria.

Acceptance Criteria Category	Specific Criteria (Implicitly ISO 6872)	Reported Device Performance	Study Proving Acceptance
Mechanical Properties	Flexural strength meets ISO 6872.	IRIS Flex materials can be raised to >300 MPa through an optional glaze firing process. Measurements showed comparable mechanical (flexural strength) to predicate and met ISO 6872.	Physical Properties Testing (Non-Clinical)
Chemical Stability	Solubility meets ISO 6872.	Measurements showed comparable chemical stability (solubility) to predicate and met ISO 6872.	Physical Properties Testing (Non-Clinical)
Biocompatibility	Meets ISO 10993-1:2009.	Characterized for cytotoxicity, intracutaneous reactivity/irritation, systemic toxicity, and genotoxicity. Results support biocompatibility.	Toxicological Testing (ISO 10993-1:2009)
Long-term Stability	Comparable to predicate device.	Verified by simulated life testing (thermal cycling, mechanical loading).	Physical Properties Testing (Non-Clinical)

2. Sample size used for the test set and the data provenance

Not Applicable for clinical performance. The document explicitly states: "No human clinical testing was conducted to support the substantial equivalence of the IRIS - High Strength Glass Ceramic." The "test set" for the non-clinical material property evaluations would refer to laboratory samples, but specific sample sizes are not provided in this summary.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No human clinical testing was performed, so there was no need for experts to establish ground truth in a clinical context. The "ground truth" for material properties is established by adherence to recognized international standards (e.g., ISO 6872, ISO 10993-1).

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

Not Applicable. Adjudication methods are relevant for human interpretation in clinical studies, which were not conducted. Validation for non-clinical testing relies on standard laboratory protocols and accredited testing facilities.

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. No human clinical testing or multi-reader studies were conducted. This device is a dental material, not an AI diagnostic tool.

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

Not Applicable. This is a dental material, not an algorithm, so the concept of standalone algorithmic performance is irrelevant. The performance is assessed based on physical and chemical properties.

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

For the non-clinical studies:

Mechanical and Chemical Properties: The ground truth is defined by international standards (ISO 6872) for dental ceramics. Comparability to a legally marketed predicate device (IPS e.max CAD) also serves as a ground truth baseline.
Biocompatibility: The ground truth is established by the accepted methods and criteria within international standard ISO 10993-1:2009 (Biological evaluation of medical devices – Part 1: Evaluation and Testing).

8. The sample size for the training set

Not Applicable. No "training set" in the context of machine learning or clinical trials was involved. If referring to laboratory samples used for initial development and optimization, that information is not provided.

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

Not Applicable. As no "training set" for an algorithm or clinical trial was used, this question is not applicable. The development of the material would follow established scientific and engineering principles for material science, with properties characterized against known material benchmarks.

Summary

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SECTION 5. 510(k) SUMMARY For IRIS

Submitter Information: 1.

DENTSPLY International Susquehanna Commerce Center 221 West Philadelphia Street York, PA 17405

Helen Lewis Contact Person: 717-849-4229 Telephone Number: 717-849-4343 Fax Number:

November 20, 2012 Date Prepared:

1. Device Name:
- IRIS High Strength Glass Ceramic Proprietary Name: .
  - Porcelain powder for clinical use Classification Name: 21CFR 872.6660
- CFR Number: .
  - Device Class: II
  - . Product Code: EIH .
Predicate Device: 3.

IPS e.max CAD (Ivoclar Vivadent, Inc.) - K051705

Description of Device: 4.
.

IRIS - High Strength Glass Ceramic is a system of glass ceramic dental materials INTO - Trigh on ongin orced lithium silicate chemistries and feldspathic veneering ceramics and accessories optimized to be compatible with IRIS glass ceramics. The system consists of:

IRIS Flex: High Strength Glass Ceramic (HSGC) CAD CAM blanks A. provided in the fully crystallized state, for machining and subsequent placement.
IRIS CAD: High Strength Glass Ceramic (HSGC) CAD CAM blanks B. provided in the partially crystallized state, for machining, crystallization firing, and subsequent placement.
Veneering ceramics provided in powder/paste forms and are intended for C. optional esthetic characterization of the CAD CAM restorations.

IRIS materials may be veneered with a compatible dental veneering ceramic or can be used as anatomically shaped full-contour restorations without veneering.

FEB 2 2 2013

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Indications for Use: 5.

IRIS is a system of precrystallized and/or fully crystallized zirconia reinforced lithium INIS is a system of processed through Ceramics processed through CAD-CAM techniques for the fabrication of:

Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and o veneers.
IRIS can be used as a substructure which is then veneered with compatible veneering ceramic or can be used for full-contour application (without veneering) as well.

Description of Safety and Substantial Equivalence: 6.

Technological Characteristics.

IRIS is system of glass ceramic materials based on zirconia-reinforced lithium silicate INIS is system or gass corains and feldspathic veneering ceramics and accessories which are optimized to be compatible with IRIS glass ceramics. The and useessories which a system and their ISO classifications and usages are outlined below.

		Table 5.1: IRIS System Components. ISO classifications and Clinical Usage.

IRIS Component	ISO 6872Classification	Clinical Usage
A: IRIS Flex: Fullycrystallized Blank	Type II, Class 2	Adhesively cemented, aesthetic or substructureceramic for single-unit anterior or posteriorprostheses.
B: IRIS CAD: PartiallyCrystallized Blank	Type II, Class 3	Aesthetic-ceramic: adhesively or non-adhesivelycemented, single-unit, anterior or posteriorprostheses
C: IRIS VeneeringCeramic	Type II, Class 1	Aesthetic ceramic for coverage of a metal or aceramic substructure.

The flexural strength of IRIS Flex materials can be raised to >300 MPa through an optional glaze firing process.

The chemical composition and technological characteristics of the IRIS - High Strength Glass Ceramic are similar to those of the predicate device.

Non-Clinical Performance Data.

Physical Properties

Measurements of the physical characteristics showed that the IRIS – High Strength Glass Ceramic materials have mechanical (flexural strength) and chemical stability (solubility) comparable to the predicate device, and meet ISO 6872 criteria for the designated indications. Simulated life testing (thermal cycling, mechanical loading) verified the long-term stability of the IRIS - High Strength Glass Ceramic in comparison with the predicate device.

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Toxicological Testing

Testing according to ISO 10993-1:2009 (Biological evaluation of medical devices – Par1 I esting according to 150 10775 1:2007 (Dioroginent process) was completed to 1. Evanianon and Testing "Minn IRIS - High Strength Glass Ceramic materials with characterize the blocompations, intracutaneous reactivity/irritation, systemic toxicity, and genotoxicity. Results of the testing conducted in accordance support the biocompatibility of the IRIS - High Strength Glass Ceramic.

Clinical Performance Data.

Not applicable. No human clinical testing was conducted to support the substantial equivalence of the IRIS - High Strength Glass Ceramic.

Conclusion Regarding Substantial Equivalence

The IRIS – High Strength Glass Ceramics have the same intended use, similar indications The the same fundamental technological characteristics as the predicate device. and the same "randamenta" conducted with reference to applicable standards as well as in remornation to the predicate device. Toxicological testing verified the biocompatibility of the IRIS - High Strength Glass Ceramic. The results of the design, intended use, and the fitter figh brongarisons as well as the results of the comparative performance testing and biocompatibility testing support the substantial equivalence of the IRIS -High Strength Glass Ceramic.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract representation of a person or a flame.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

February 22, 2013

Ms. Helen Lewis Director, Corporate Regulatory Affairs DENTSPLY International, Incorporated 21 West Philadelphia Street, Suite 60W YORK PA 17405

Re: K123615

Trade/Device Name: IRIS - High Strength Glass Ceramic Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: November 20, 2012 Received: November 29, 2012

Dear Ms. Lewis:

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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Page 2 - Ms. Lewis

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 devicerelated 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Image /page/4/Picture/6 description: The image shows the name "Kwame O. Ulmer" in bold, black font. The letters "FDA" are in the middle of the name, with the "O" in Kwame and the "U" in Ulmer overlapping the letters. The letters "FDA" are stylized with a geometric pattern.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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SECTION 4. INDICATIONS FOR USE STATEMENT

123612

510(k) Number (if known):

Device Name: IRIS - High Strength Glass Ceramic

Indications for Use:

IRIS - High Strength Glass Ceramic is a system of precrystallized and/or fully crystallized IRIS - High Strength Glass Ceramics and veneering ceramics processed through
zirconia reinforced lithium silicate glass ceramics and veneering ceramics processed through
out CAD-CAM techniques for the fabrication of:

Single unit dental restorations, for example all-ceramic crowns, inlays, onlays and . veneers.
veneurs as a substructure which is then veneered with IRIS veneering ceramic or can be used for full-contour application (without veneering) as well.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE—CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner, DOSMA	Mary S. Runner
	2013.02.14
	10:20:01 -05'00'

Division Sign-Off) (Division Sign-On)
Division of Anesthealology, General Hospital Infection Control, Dental Devices

510(k) Number:

IRIS - High Strength Glass Ceramic

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.