The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth.
· May be used as a direct restorative material
· May be used for fabrication of inlays and onlays

Device Description

The Camouflage Nanohybrid Composite (Universal and Flowable) is a light cured resin-based composite restorative. It is offered in High Viscosity ("Camouflage Universal" paste) and Low Viscosity (Camouflage Flowable), and is recommended for direct and indirect placement in all caries classes (both anterior and posterior restorations, including occlusal surfaces). It is available in multiple shades and opacities, and is radioopaque. It is composed of methacrylate monomers, Initiators, inhibitors, stabilizers, pigments, and inorganic fillers coated with a coupling agent. The Camouflage Nanohybrid Composite (Universal and Flowable) cures with light in the wavelength range of 400-500nm, and a dental adhesive is used to permanently bond the restoration to the tooth structure.

AI/ML Overview

The provided document is a 510(k) summary for a dental composite material, the "Camouflage NanoHybrid Composite (Universal and Flowable)." It focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technological characteristics. This document does NOT describe a study involving a device that requires ground truth established by experts, or human readers, or that involves AI assistance.

Therefore, I cannot provide information on:

Sample size used for the test set and data provenance: No test set is described in the context of expert review or AI evaluation.
Number of experts used to establish the ground truth for the test set and their qualifications: No expert ground truth establishment is described.
Adjudication method for the test set: No adjudication method is described.
Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
Standalone (algorithm only without human-in-the-loop performance) study: This type of study is not mentioned.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.) for a test set: No test set ground truth is established as described.
Sample size for the training set: There is no mention of a training set as this is not an AI or diagnostic imaging device.
How the ground truth for the training set was established: Not applicable.

This document describes the following in relation to acceptance criteria and the study that proves the device meets them:

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

The document implicitly uses ISO 4049: 2009 "Dentistry - Polymer-based restorative materials" requirements as acceptance criteria. However, explicit quantitative acceptance criteria values are not provided in the summary. Instead, the document states that the device was "evaluated using the relevant FDA recognized standard: ISO 4049: 2009" and that Prismatik "performed various testing...to provide evidence, assurance for the device safety and meeting the ISO 4049 requirements."

The document also provides a comparison table of technological characteristics between the proposed device and the predicate device. For each characteristic, it states "Same" indicating that the proposed device performs equivalently or meets the same specifications as the predicate device, which is implied to have already met relevant standards.

Characteristic	Predicate Device (Composite 168 Restorative System)	Proposed Device (Camouflage Nanohybrid Composite)	Reported Device Performance (Similarity to Predicate)
Classification of Polymer (Per ISO 4049)	Type-1, Class-2, Group- 1&2	Type-1, Class-2, Group- 1&2	Same
Intended Uses Per FDA Regulation	Intended to restore carious lesions or structural defects in teeth	Intended to restore carious lesions or structural defects in teeth	Same
Indications for use per 510k Clearance Letter	• Indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. • May be used as a direct restorative material • May be used for fabrication of inlays and onlays	• Indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth. • May be used as a direct restorative material • May be used for fabrication of inlays and onlays	Same
FDA Description and Product Code Information (EBF)	21 CFR 872.3690 (Tooth shade resin material)	21 CFR 872.3690 (Tooth shade resin material)	Same
General Material	Tooth shade resin material	Tooth shade resin material	Same
Delivery Method(s)	• Syringes • Capsules Tips	• Syringes • Capsules Tips	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Sterility	Non-Sterile	Non-Sterile	Same
Single or Multiple Use	Single Patient, multiple use	Single Patient, multiple use	Same
Prescription/OTC Use	Prescription	Prescription	Same
Specific Non-Clinical Tests (implicit acceptance based on ISO 4049 requirements met)			Results (Implicitly met ISO 4049 requirements)
Sensitivity to Ambient Light	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Depth of Cure	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Flexural Strength/Elastic Modulus	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Water Absorption	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Water Solubility	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Shade Match/Shade Stability	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements
Radio Opacity	(Not specified, assumed to meet ISO 4049)	(Not specified, assumed to meet ISO 4049)	Met ISO 4049 requirements

The Study that Proves the Device Meets Acceptance Criteria:

The study that proves the device meets acceptance criteria is a non-clinical testing study designed to demonstrate substantial equivalence to a predicate device.

H. Summary of Non-Clinical Testing:

Study Design: Non-clinical (benchtop) testing.
Testing Protocol: The Camouflage Nanohybrid Composite (Universal and Flowable) was evaluated against the relevant FDA-recognized standard: ISO 4049: 2009 Dentistry - Polymer-based restorative materials. Additionally, the study referenced the FDA's "Guidance for Industry and FDA Staff - Dental Composite Resin Devices - Premarket Notification [510(k)] Submissions."
Specific Tests Performed:
- Sensitivity to Ambient Light
- Depth of Cure
- Flexural Strength/Elastic Modulus
- Water Absorption
- Water Solubility
- Shade Match/Shade Stability
- Radio Opacity

I. Conclusion from the Non-Clinical Testing:

The results of these tests demonstrated that the Camouflage NanoHybrid Composite (Universal and Flowable) is substantially equivalent to the cleared predicate device, the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. This substantial equivalence implies that the proposed device meets the same safety and effectiveness standards as the predicate device, which is presumed to have met the necessary acceptance criteria (e.g., ISO 4049).

Summary

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Image /page/0/Picture/0 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a black triangle on the left and the company name on the right. The company name is written in a bold, sans-serif font.

005-510(k) Summary-807.92(c)

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

SUBMITTER INFORMATION A.

Company Name:	Prismatik Dentalcraft, Inc.
Company Address:	2212 Dupont Dr., Suite IJK,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
Secondary Contact Person	Marilyn Pourazar, (949) 225-1269Senior Director, RA/QA
Date Summary Prepared:	June 3, 2014

DEVICE IDENTIFICATION B.

Trade/Proprietary Name:	Camouflage NanoHybrid Composite (Universal andFlowable)
21 CFR Reference:	21 CFR 872.3690
21 CFR Common Name:	Tooth shade resin material
Classification:	Class II
Product Code:	EBF
Panel:	Dental

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C. IDENTIFICATION OF PREDICATE DEVICE

Trade/Proprietary Name:

Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221

DEVICE DESCRIPTION D.

INDICATIONS FOR USE E.

The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV, V, and VI in anterior and posterior teeth.

· May be used as a direct restorative material

· May be used for fabrication of inlays and onlays

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 Camouflage NanoHybrid Composite (Universal and Flowable) with the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221, The following comparison table of the technological characteristics of the proposed device and the predicate device outlines and provides the similarities and the substantial equivalency of the Camoutlage NanoHybrid Composite (Universal and Flowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221.

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	Predicate Device:Composite 168Restorative System(EsthetXHD/Flow)Dentsply510(k)-K973221	Proposed Device:Camouflage NanohybridComposite(Universal and Flowable)	SimilaritiesandDifferenceBetween thePredicate andthe SubjectDevice
Classification ofPolymer	Per ISO 4049Type-1Class-2Group- 1&2(Per ISO 4049)	Per ISO 4049Type-1Class-2Group- 1&2(Per ISO 4049)	Same
Intended Uses PerFDA Regulation	Intended to restore cariouslesions or structural defectsin teeth	Intended to restore cariouslesions or structural defects inteeth	Same
Indications for useper 510kClearance Letter	• Indicated for cavityclasses I, II, III, IV, V, andVI in anterior and posteriorteeth.• May be used as a directrestorative material• May be used forfabrication of inlays andonlays	• Indicated for cavity classes I,II, III, IV, V, and VI inanterior and posterior teeth.• May be used as a directrestorative material• May be used for fabricationof inlays and onlays	Same
FDA Descriptionand Product CodeInformation	EBF21 CFR 872.3690Tooth shade resin material	EBF21 CFR 872.3690Tooth shade resin material	Same
General Material	Tooth shade resin material	Tooth shade resin material	Same
Delivery	• Syringes	• Syringes	Same
Method(s)	• Capsules Tips	• Capsules Tips	Same
Biocompatibility	Biocompatible	Biocompatible	Same
Sterility	Non-Sterile	Non-Sterile	Same
Single or MultipleUse	Single Patient, multiple use	Single Patient, multiple use	Same
Prescription/OCTUse	Prescription	Prescription	Same

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

G. DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The above comparison table of the technological characteristics of the proposed device and the predicate devices was provided for the substantial equivalency of the Camouflage NanoHybrid Composite (Universal and Fiowable) and the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221. Prismatik believes that the comparative

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data presented, demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is 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. Both the proposed and the predicate device consist of the same Product Code: EBF, which is 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 Camouflage Nanohybrid Composite (Universal and Flowable) was 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, assurance for the device safety and meeting the ISO 4049 requirements. Prismatik performed various testing including the Sensitivity to Ambient Light, Depth of Cure, Flexural Strength/Elastic Modulus, Water Absorption, Water Solubility, Shade Match/Shade Stability and Radio Opacity.

CONCLUSION FROM THE NON-CLINICAL TESTING I.

The results of the above described studies demonstrate that the Camouflage NanoHybrid Composite (Universal and Flowable) is substantially equivalent to the cleared predicate device, the Composite 168 Restorative System (EsthetXHD/Flow) Dentsply-K973221.

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

June 4, 2014

Prismatik Dentalcraft, Inc. C/O Mr. Armin Zehtabchi Senior Regulatory Analyst 2212 Dupont Drive, Suite IJK Irvine, CA 92612

Re: K133850

Trade/Device Name: Camouflage Nanohybrid Composite Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade, resin Regulatory Class: Il Product Code: EBF Dated: April 29, 2014 Received: April 30, 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.

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Page 2 - Mr. Zehtabchi

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 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 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/ResourcesforYou/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 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 vours.

MarylSTByner-S

Erin I. Keith, M.S. 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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Image /page/6/Picture/1 description: The image shows the logo for Prismatik Dentalcraft, Inc. The logo consists of a triangle on the left and the company name on the right. The triangle is filled with a dark color and has a textured appearance. The company name is written in a bold, sans-serif font.

Page 12 of 186

004-Indications for Use Statement

510(k) Number (if known): To be determined

Camouflage Nanol lybrid Composite (Universal and Flowable) Device Name:

Indications for Use: The Camouflage NanoHybrid Composite (Universal and Flowable) are indicated for cavity classes I, II, III, IV. V, and VI in anterior and posterior teeth.

· May be used as a direct restorative material

· May be used for fabrication of inlays and onlays

Prescription Use:	Yes X No
	(Part 21 CFR 801 Subpart D)

Over-the-Counter Use: Yes | No Z (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green:=S
2014.06.03 14:52:53-04'00'

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.