Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns, and bridges.
For use by or on the order of a dental professional.

Device Description

The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.

AI/ML Overview

The provided text describes a 510(k) submission for a dental CAD/CAM material called "Crystal® Ultra." This device is a material, not an AI-powered diagnostic tool, and therefore most of the requested information about acceptance criteria, study design, and ground truth establishment for AI performance metrics are not applicable.

However, I can extract the relevant information regarding the non-clinical performance data and how the device's equivalence was established.

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

The submission states that bench testing was performed in accordance with FDA recognized standards and compared to predicate devices. The "acceptance criteria" here are implicitly the satisfactory performance against these standards and demonstrating substantial equivalence to the predicate devices. The reported device performance is that it met these criteria.

Performance Metric (Standard)	Acceptance Criteria (Implicit)	Reported Device Performance
Flexural Strength (ISO 6872)	Comparable to predicate devices	Substantially equivalent to predicate devices
Chemical Solubility (ISO 10477)	Comparable to predicate devices	Substantially equivalent to predicate devices
Elasticity (ISO 10477)	Comparable to predicate devices	Substantially equivalent to predicate devices
Compressive Strength (ISO 10477)	Comparable to predicate devices	Substantially equivalent to predicate devices
Density (ISO 10477)	Comparable to predicate devices	Substantially equivalent to predicate devices
Water Absorption (ISO 4049)	Comparable to predicate devices	Substantially equivalent to predicate devices
Shade Stability (ISO 4049)	Comparable to predicate devices	Substantially equivalent to predicate devices
Color Consistency (ISO 4049)	Comparable to predicate devices	Substantially equivalent to predicate devices
Water Solubility (ISO 4049)	Comparable to predicate devices	Substantially equivalent to predicate devices
Radioactivity	Assessed for safety	Included in testing, results are satisfactory for substantial equivalence
Storage Stability	Assessed for performance over time	Included in testing, results are satisfactory for substantial equivalence
Bond Strength	Assessed for clinical application	Included in testing, results are satisfactory for substantial equivalence
Modulus of Elasticity	Assessed for mechanical properties	Included in testing, results are satisfactory for substantial equivalence
Biocompatibility (ISO 10993)	Meets biocompatibility standards for dental materials	Concluded to be substantially equivalent in safety to predicate device

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 does not specify the sample sizes for the bench tests. The tests were performed in accordance with FDA recognized standards (ISO 6872, ISO 10477, ISO 7405, ISO 4049, ISO 10993). These are likely laboratory bench tests, not clinical studies involving human patients or specific geographical data provenance. Therefore, terms like "retrospective or prospective" are not applicable.

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 is not applicable as the device is a material, and the "ground truth" for its performance is established through standardized physical and chemical testing, not expert interpretation of cases.

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

This is not applicable for a material test. The "adjudication" is based on the results of standardized laboratory tests against predefined specifications.

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

This is not applicable. This device is a material, not an AI or diagnostic tool that would involve human readers.

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

This is not applicable as the device is a material, not an algorithm.

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

The "ground truth" for this device's performance is derived from standardized physical and chemical measurements obtained through bench testing according to ISO standards (e.g., flexural strength, solubility, density). The comparison is made to the established performance characteristics of legally marketed predicate dental materials.

8. The sample size for the training set

This is not applicable as the device is a dental material, not an AI algorithm requiring a training set.

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

This is not applicable as there is no training set for this type of device.

Summary

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K130654

510(k) Summary

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Dental Laboratory Milling Supplies

Submitter	Dental Laboratory Milling Supplies, LLC (DLMS)14201 N 87th Street #A-105, Scottsdale, AZ 85260
Contact	Scott Atkin, President, 480-948-0466email: scott@dentalzirconia.com
510(k) Number	K130654	SEP 2 4 2013
Date Prepared	Revised on September 9, 2013Original submitted on Feb 11, 2013
Trade/Device Name	Crystal® Ultra
Common Name	Dental CAD/CAM Material
Classification Names	Porcelain Powder for Clinical Use (21 CFR 872.6660, Product Code EIH)Tooth Shade Resin Material (21 CFR 872.3690, Product Code: EBF)
Predicate Device(s)	"Lava Ultimate CAD/CAM Restorative for CEREC/ E4D, Lava Ultimate Implant CrownRestorative," K110131, dated 1/21/11, and Vita "Enamic," K122269, dated 12/13/12
Device Description	The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networksof glass ceramic and polymer material to form a solid block of material. The uniquemarriage of the two materials creates a dual-network hybrid, which lends the positivephysical properties of each individual material to the other. This results in a materialwith significantly lower brittleness compared to a pure ceramic and better abrasionbehavior than a pure resin, (similar to natural enamel). The material is milled in adental CAD/CAM machine into its restorative form.
Statement of Intended Use	Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays,veneers, crowns, and bridges.
Substantial Equivalence	Information provided in this application shows that the product is substantiallyequivalent to the predicate devices. Both Crystal® Ultra and the predicate devicesare composite ceramic and resin materials. The blending of these two proven dentalmaterials creates beneficial physical properties while remaining compliant to the FDArecognized consensus standards applied to these material types. Bench testing wasperformed on Crystal® Ultra in accordance to FDA recognized standards andcompared to predicate devices as per ISO 6872, ISO 10477, ISO 10993, ISO 4049,and ISO 7405, including bench testing and comparative analysis of flexural strength,chemical solubility, elasticity, compressive strength, density, water absorption, shadestability, color consistency, and water solubility. Comparisons of the physicalproperties of the Crystal® Ultra to the predicate devices are included in thisapplication, which illustrate that they are substantially equivalent.
Design Characteristics	The geometry of the Crystal® Ultra material is shaped into block or disc forms asdefined by the CAD/CAM manufacturer. The material will be inserted in to the CAMmachine and milled into its final form, then polished and ready for placementthereafter.

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Material Characteristics .......... The majority volume of the Crystal® Ultra material is made up of a ceramic material similar to the predicate devices and used commonly in dentistry. The remaining volume of the block is made up of resin. This combination of ceramic and resin material is similar to the Vita Enamic and Lava Ultimate predicates. Comparisons of the material composition to the two predicates to the Crystal® Ultra are included in this application.
Biocompatibility ............................................................................................................................................................. FDA Recognized ISO 10933 standards. This assessment, included in this application, concluded that the device substantially equivalent in safety (and effectiveness) to the predicate device.
Non-Clinical Performance Data. Bench testing was performed in accordance to FDA recognized standards ISO 6872, ISO 10477, ISO 7405, and ISO 4049 which includes ISO testing of flexural strength, solubility, radioactivity, storage stability, color stability, color consistency, plus additional evaluation of bond strength, modulus of elasticity and compressive strength. The results of this testing allowed us to conclude that Crystal® Ultra is substantially equivalent in safety (and effectiveness) to the predicate device. Test results are included in this application.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

September 24, 2013

Dental Laboratory Milling Supplies, L.L.C. C/O Mr. Scott Atkin President 14201 North 87th Street. Suite A-101 Scottsdate, AZ 85260

Re: K130654

Trade/Device Name: Crystal® Ultra Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH, EBF Dated: August 20, 2013 Received: August 26, 2013

Dear Mr. Atkin:

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 - Mr. Mr. Atkin

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 Acc 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/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/Reportal"roblem/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/ResourcesforYou/Industry/default.htm.

Sincercly yours.

Richard C. Chapman

for

Kwame Ulmer M.S. Acting Division 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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Indications for Use Statement

510(k) Number (if known): K130654

Device Name: Crystal Uitra

Indications for Use:

Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.

For use by or on the order of a dental professional.

Prescription Use × (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)

Andrew I. Steen 2013.09.24 11:35:48 -04'00'

(Division Sign-O11) swiston of Anesthastology, General Heaptel ntection Control, Dental Devices

510(k) Number K130654

Dental Laboratory Milling Supplies, 14201 N 87th St #A-101, Scottsdale, AZ 85260

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.