CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.

Device Description

The CAD/CAMouflage Milling Block is a nanohybrid composite material that is designed as an indirect restorative for both anterior and posterior restorations including occlusal surfaces. The CAD/CAMouflage Milling Block is made for fabricating indirect restorations such as inlays, onlays, veneers and full crown restorations, including crowns. The mandrel is solely to aid in the manipulation of the material during processing (grinding, shaping, cutting, etc.). It is removed prior to the material (subject device) being put into final placement. As such, there are no implications for device performance or safety, since it is removed, and it has no patient contact.

AI/ML Overview

The provided document is a 510(k) Summary for a dental device, the CAD/CAMouflage Milling Block. This type of submission focuses on demonstrating substantial equivalence to a predicate device, primarily through non-clinical testing of material properties, rather than clinical efficacy studies often associated with AI/ML devices. Therefore, many of the requested points related to AI/ML device studies (like sample size for test set, number of experts for ground truth, adjudication methods, MRMC studies, and training set details) are not applicable or cannot be extracted from this document.

Here's the information that can be extracted, primarily focusing on the non-clinical testing for material properties:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that the device was evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials, and ISO 10477:2004(E). It also mentions various tests performed: Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, and Compressive Strength. However, the specific acceptance criteria values from these ISO standards for each test, and the reported device performance values for the CAD/CAMouflage Milling Block, are not explicitly provided in this summary. The summary only states that the device meets the requirements.

A conceptual representation based on the text (actual values are missing):

Test Name	Acceptance Criteria (from ISO 4049:2009, ISO 10477:2004(E))	Reported Device Performance (CAD/CAMouflage Milling Block)
Flexural Strength	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Water Sorption	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Water Solubility	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Radio Opacity	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Shade Stability	Specific criteria from ISO standard	Meets criteria (details not provided)
Diametral Strength	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Compressive Strength	Specific value/range from ISO standard	Meets criteria (exact value not provided)
Biocompatibility	Biocompatible (based on relevant standards)	Biocompatible

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

Sample Size for Test Set: Not specified in the document. Non-clinical material testing typically uses a certain number of samples for each test type according to the relevant ISO standards, but the exact count is not given here.
Data Provenance: The tests were performed by Prismatik Dentalcraft, Inc. The document implies these are internal laboratory tests. There is no information about country of origin of data, nor whether it is retrospective or prospective, as these terms are generally not applicable to laboratory material property testing in the same way they are for clinical studies.

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

This is not applicable. The "ground truth" for material properties is established by objective physical and chemical measurements following standardized protocols (like ISO 4049). It does not involve expert interpretation or consensus in the context of this type of device and study.

4. Adjudication method for the test set

This is not applicable. As these are objective material property tests, there is no need for adjudication as one would find in a clinical or image-interpretation study.

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 is not an AI/ML device, nor is it a device that involves human readers or interpretation. It is a dental restorative material.

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

This is not applicable. This is not an AI/ML algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance relies on objective physical and chemical measurements conducted according to recognized international standards (ISO 4049:2009 and ISO 10477:2004(E)) for dental polymer-based restorative materials. These standards define the methods and criteria for evaluating properties like flexural strength, water sorption, water solubility, radio opacity, shade stability, diametral strength, and compressive strength.

8. The sample size for the training set

This is not applicable. This device is a material, not an AI/ML algorithm that requires a "training set."

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

This is not applicable. There is no training set for this device.

Summary

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

July15, 2016

Prismatik Dentalcraft, Inc. Maria Wagner Senior RA 2212 Dupont Drive, Suite P Irvine, California 92612

Re: K160425

Trade/Device Name: CAD/CAMouflage Milling Block Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 15, 2016 Received: June 16, 2016

Dear Ms. Wagner:

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 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.

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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/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

Enclosure

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Indications for Use

510(k) Number (if known) K160425

Device Name

CAD/CAMouflage Milling Block

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)

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Image /page/3/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. On the left is a triangle with a rainbow gradient. To the right of the triangle is the company name, "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the second line. The text is in a blue sans-serif font.

510(k) Summary

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

SUBMITTER INFORMATION A.

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	2212 Dupont Dr., Suite P.Irvine, CA 92612
Company Phone:	949-440-2636
Company FAX:	949-553-0924
Facility Registration Number:	3005477956
Primary Contact Person:	Maria E Wagner, (949) 440-2636Senior Specialist, Regulatory Affairs
Secondary Contact Person	Lisa Maloney, (949) 440-2631Sr. Manager, Regulatory Affairs
Date Summary Prepared:	July 14, 2016

DEVICE IDENTIFICATION B.

Trade/Proprietary Name:	CAD/CAMouflage Milling Block
Reference:	21 CFR 872.3690
Classification Name:	Material, Tooth Shade Resin
Classification:	Class II
Product Code:	EBF, EBG
Panel:	Dental

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C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:	CAD/CAMouflage Milling Block
Primary Device:	CERASMART ™ -K133824
Reference Device:	Camouflage Nanohybrid Composite-K133850

DEVICE DESCRIPTION D.

E. INDICATIONS FOR USE

F. SUMMARY OF THE TECHNOLOGICAL CHARACTERISTICS OF THE PROPOSED DEVICE AND THE PREDICATE DEVICES

Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions for comparing its CAD/CAMouflage Milling Blocks with the Primary Device: CERASMART™ and reference device: Prismatik's Camouflage Nanohybrid Composite. The following comparison table of the technological characteristics of the proposed device, the predicate and reference devices outlines and provides the similarities and the substantial equivalency of the CAD/CAMouflage Milling Blocks and the cited predicate and reference devices.

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Comparison of Technological Characteristics of the Proposed Device and the Predicate Devices

Attributes	Reference Device:CamouflageNanoHybridComposite510(k)-K133850Prismatik Dentalcraft,Inc.	Predicate Device:Cerasmart510(k)-K133824GC AMERICA,INC.	ProposedDevice:CAD/CAMouflage MillingBlocksPrismatikDentalcraft,Inc.	Similarities &Differences
FDAClassificationName	Tooth shade resinmaterial	Tooth shade resinmaterial	Tooth shaderesin material	Same
FDA ProductCode	EBF	EBF, EBG	EBF, EBG	Similar to PredicateDeviceSame as ReferenceDevice
FDA DeviceClassification	Class II per 21 CFR872.3690	Class II per 21 CFR872.3690	Class II per 21 CFR872.3690	Same
ChemicalComposition	Composite RestorativeMaterial	CompositeRestorative Material	Composite RestorativeMaterial	Similar to PredicateDevice: Similar toReference Device
Intended Use	Intended to restorecarious lesions orstructural defects inteeth	The product isindicated for inlays,onlays, veneers andfull crownrestorations,including crownson implants	Intended to restorecarious lesions orstructural defects inteeth	Same as PredicateDevice; Similar toReference Device
Indications	Cavity classes I, II, III,IV, V and VI in anteriorand posterior teeth; usedas direct restorativematerial; can use forfabrication of inlays andonlays	Indicated for inlays,onlays, veneers andfull crownrestorations,including crowns onimplants	CAD/CAMouflageMilling Block isindicated as an indirectrestorative for bothanterior and posteriorrestorations, includingocclusal surfaces. TheCAD/CAMouflageMilling Block is madefor fabricatingtemporary andpermanent restorationssuch as inlays, onlays,veneers and full crownrestorations.	Same as PredicateDevice; Similar toReference Device
Biocompatibility	Biocompatible	Biocompatible	Biocompatible	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Single orMultiple Use	Single Patient, multipleuse	Single Patient,multiple use	Single Patient, multipleuse	Same
Prescription/OCTUse	Prescription	Prescription	Prescription	Same
SubstantialEquivalence	The proposed device has comparable indications, intended use, biocompatibility, chemicalcomposition, mechanical and chromatic properties to the predicate device, and has similarcharacteristics to the reference device. We consider the proposed device to be substantiallyequivalent to the predicate device, and believe any differences between the proposed and predicate& reference devices will not pose new equvalency concerns.

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G. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The above comparison table of the technological characteristics of the proposed device and the predicate and reference devices was provided for the substantial equivalency of the CAD/CAMouflage Milling Blocks with the Primary Device: CERASMART™-K133824 and the referenced device: Prismatik's Camouflage Nanohybrid Composite-K133850, and reference device: Prismatik believes that the comparative data presented, demonstrate that the CAD/CAMouflage Milling Blocks are essentially the same as currently marketed devices for the same indications for use, and supports our claim of substantial equivalence to predicate Class II devices under the classification of 21 CFR 872.3690 that have previously been found to be substantially equivalent. The proposed, the predicate and reference devices consist of the same/similar Product Code: EBF, EBG, which are biocompatible for the same indications for use.

H. SUMMARY OF NON-CLINICAL TESTING

Non-clinical test data was used to support the substantial equivalency. Specifically, the CAD/CAMouflage Milling Blocks were evaluated using the relevant FDA recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. In addition. Prismatik utilized the FDA's Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions. To provide evidence and assurance for the device safety and meeting the ISO 4049 and ISO 10477:2004(E) requirements, Prismatik performed various testing including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength and biocompatibility.

I. CONCLUSION FROM THE NON-CLINICAL TESTING

The results of the above described studies demonstrate that the CAD/CAMouflage Milling Blocks are substantially equivalent to the cleared Primary Device: CERASMART™-K133824 and reference device: Prismatik's Camouflage Nanohybrid Composite-K133850.

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.