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. 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 text describes a 510(k) summary for a dental device, the CAD/CAMouflage Milling Block, which is a nanohybrid composite material for indirect dental restorations. The core of the submission is to demonstrate substantial equivalence to a previously cleared predicate device (K160425).

Here's an analysis of the provided information concerning acceptance criteria and the study that proves the device meets them:

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

The document does not explicitly present a table of "acceptance criteria" against "reported device performance" in a quantitative sense as might be seen for diagnostic accuracy or clinical outcomes. Instead, it demonstrates substantial equivalence to a predicate device based on technological characteristics and non-clinical testing against recognized standards.

The closest representation of "acceptance criteria" are the parameters for which the proposed device must be "Same" as the predicate or meet specific ISO standards for mechanical and chemical properties.

Characteristic / Acceptance Criteria	Reported Device Performance (Proposed Device)	Comparison to Predicate Device (K160425)
FDA Classification Name: Tooth shade resin material	Tooth shade resin material	Same
FDA Product Code: EBF	EBF	Same
FDA Device Classification: Class II per 21 CFR 872.3690	Class II per 21 CFR 872.3690	Same
Chemical Composition: Composite Restorative Material	Composite Restorative Material	Same
Intended Use: Intended to restore carious lesions or structural defects in teeth	Intended to restore carious lesions or structural defects in teeth	Same
Indications: CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.	CAD/CAMouflage Milling Block is indicated as an indirect restorative for both anterior and posterior restorations, including occlusal surfaces. Made for fabricating temporary and permanent restorations such as inlays, onlays, veneers and full crown restorations.	Same
Biocompatibility: Biocompatible	Biocompatible	Same
Sterility: Non-Sterile	Non-Sterile	Same
Single or Multiple Use: Single use	Single use	Same
Prescription/OTC Use: Prescription	Prescription	Same
Final Vita Shades: A2 LT (Predicate)	A1 HT, A2 HT, A3 HT, A3.5 HT, B1 HT, A1 LT, BL LT, A3 LT, A3.5 LT, B1 LT, C2 LT, D2 LT	Different (Proposed device has additional shades)
Mechanical Properties (e.g., Flexural Strength, Diametral Strength, Compressive Strength): Meets relevant FDA recognized standards (ISO 4049:2009, ISO 10477:2004(E))	Tested against these standards	Demonstrated to meet standards
Chemical Properties (e.g., Water Sorption and Solubility, Radio Opacity, Shade Stability): Meets relevant FDA recognized standards (ISO 4049:2009, ISO 10477:2004(E))	Tested against these standards	Demonstrated to meet standards

Study Proving Acceptance Criteria:

The study proving the device meets the "acceptance criteria" is a non-clinical testing study designed to demonstrate substantial equivalence to the predicate device and compliance with relevant international standards.

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

The document does not specify the exact sample sizes (e.g., number of blocks tested for each property) used for the non-clinical testing. It broadly states that "Prismatik performed various tests including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength."

The data provenance is not explicitly stated in terms of country of origin or whether it's retrospective/prospective, but it's generated by the manufacturer (Prismatik Dentalcraft, Inc.) for the purpose of this 510(k) submission, implying it's a prospective internal company study.

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

This information is not applicable as the evaluation is based on non-clinical, physical, and chemical property testing against international standards, not on expert adjudication of clinical outcomes or images. The "ground truth" here refers to the quantitative values defined by the ISO standards.

4. Adjudication method for the test set

This information is not applicable for the same reason as point 3. The assessment is objective, based on material property measurements.

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 information is not applicable. This device is a dental material (milling block), not an AI-powered diagnostic or assistive technology for human readers. Therefore, no MRMC study or AI assistance evaluation would be relevant or performed.

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

This information is not applicable. The device is a physical dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the non-clinical testing is defined by international consensus standards for dental materials:

ISO 4049: 2009 Dentistry - Polymer-based restorative materials
ISO 10477:2004(E) Dentistry - Polymer-based crown and veneering materials

These standards specify the acceptable ranges for various physical and chemical properties of dental restorative materials.

8. The sample size for the training set

This information is not applicable. This is a material science product, not a machine learning model. There is no concept of a "training set" in this context.

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

This information is not applicable for the same reason as point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, representing health and human services.

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

November 16, 2016

Prismatik Dentalcraft, Inc. Lisa Maloney Sr. Manager, Regulatory Affairs 2212 Dupont Drive, Suite P Irvine, California 92612

Re: K162537

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: October 14, 2016 Received: October 17, 2016

Dear Ms. Lisa Maloney:

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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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.

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No.	0910-0120
Expiration Date:	January 31, 2017
	See PRA Statement below.

510(k) Number (if known)
Device Name	CAD/CAMouflage Milling Block
Indications for Use (Describe)	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.

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)
-------------------------------------------------	-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (301) 443-6740
EF

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Image /page/3/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 a 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:	Aliva Das, (949) 225-1249Regulatory Affairs Associate
Secondary Contact Person	Lisa Maloney, (949) 440-2631Sr. Manager, Regulatory Affairs
Date Summary Prepared:	October 14, 2016

B. DEVICE IDENTIFICATION

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

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C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:	CAD/CAMouflage Milling Block
Predicate Device:	CAD/CAMouflage Milling Block
Predicate Clearance Number/Date:	K160425; July 15, 2016

D. DEVICE DESCRIPTION

E. INDICATIONS FOR USE

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

Prismatik utilized the FDA's Guidance for Industrv and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions for comparing its CAD/CAMouflage Milling Blocks with the Primary Device: CAD/CAMouflage Milling Block (K160425) cleared on July 15, 2016. There are no changes in the technological characteristics of the proposed device, and the predicate device. Outlined below are the similarities and the substantial equivalency of the CAD/CAMouflage Milling Blocks and the cited predicate device:

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

Attributes	Predicate Device: 510(k)K160425CAD/CAMouflageMilling BlockPrismatik Dentalcraft, Inc.	Proposed Device:CAD/CAMouflage MillingBlock	Similarities&Differences
FDAClassificationName	Tooth shade resin material	Tooth shade resin material	Same
FDA ProductCode	EBF	EBF	Same
FDA DeviceClassification	Class II per 21 CFR 872.3690	Class II per 21 CFR 872.3690	Same
ChemicalComposition	Composite Restorative Material	Composite Restorative Material	Same
Final Vita Shades	A2 LT	A1 HT,A2 HT,A3 HT,A3.5 HT, B1HT, A1 LT, BL LT, A3 LT, A3.5LT, B1 LT, C2 LT, D2 LT,	Different
Intended Use	Intended to restore cariouslesions or structural defects inteeth	Intended to restore carious lesionsor structural defects in teeth	Same
Indications	CAD/CAMouflage MillingBlock is indicated as an indirectrestorative for both anterior andposterior restorations, includingocclusal surfaces. TheCAD/CAMouflage MillingBlock is made for fabricatingtemporary and permanentrestorations such as inlays,onlays, veneers and full crownrestorations.	CAD/CAMouflage Milling Block isindicated as an indirect restorativefor both anterior and posteriorrestorations, including occlusalsurfaces. The CAD/CAMouflageMilling Block is made forfabricating temporary andpermanent restorations such asinlays, onlays, veneers and fullcrown restorations.	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Sterility	Non-Sterile	Non-Sterile	Same
Single orMultiple Use	Single use	Single use	Same
Prescription/OTCUse	Prescription	Prescription	Same
SubstantialEquivalence	The proposed device has the same indications, intended use, biocompatibility, andchemical composition, mechanical and chromatic properties to the predicate device. Weconsider the proposed device to be substantially equivalent to the predicate device, andbelieve any differences between the proposed and predicate devices will not pose newsafety or effectiveness concerns. The intended use of the modified device has notchanged as a result of the modification.

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DETERMINATION OF SUBSTANTIAL EQUIVALENCE G.

The comparison table above outlines and provides the similarities and substantial equivalency of the technological characteristics of the predicate device. CAD/CAMouflage Milling Block K160425 and the proposed device CAD/CAMouflage Milling Block. 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 intended use, 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 and predicate devices consist of the same Product Code: EBF, and are biocompatible for the same indications for use. The only change is to include the additional shades to the CAD/CAMouflage Milling Blocks.

SUMMARY OF NON-CLINICAL TESTING H.

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 tests including the Flexural Strength, Water Sorption and Solubility, Radio Opacity, Shade Stability, Diametral Strength, Compressive Strength. Biocompatibility was provided in the predicate device.

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: CAD/CAMouflage Milling Blocks: K160425.

The modification for our CAD/CAMouflage Milling Block is to add additional shades as provided in the Comparison Table above.

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.