BRILLIANT Crios is a radiopaque composite material composed of crosslinked methacrylate based polymerized monomers and dental glass fillers. The subject device is made available in block forms of different sizes, shades and translucencies for the fabrication of permanent tooth restorations such as inlays, onlays, crowns and veneers using CAD/CAM milling equipment.

AI/ML Overview

This document is a 510(k) summary for a dental restorative material called BRILLIANT Crios. It focuses on demonstrating substantial equivalence to a predicate device, CERASMART™, rather than providing detailed acceptance criteria and study results for a diagnostic AI device.

Therefore, the provided text does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving device performance for an AI/diagnostic device.

The document describes the physical and mechanical properties of the BRILLIANT Crios material and compares them to a predicate device, CERASMART™, and a reference device, SYNERGY®. It also mentions that the company conducted performance and biocompatibility testing.

Here's what can be extracted, though it doesn't directly answer your specific questions in the context of an AI/diagnostic device:

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

The document provides a comparison table (Table 5-1) for physical and mechanical properties. While not explicitly "acceptance criteria" in the AI sense, these are performance metrics for a dental material.

Attributes	Predicate Device (CERASMART™)	Subject Device (BRILLIANT Crios)
Flexural Strength	160 (MPa)	198 (MPa)
Flexural Modulus of Elasticity	8.3 (GPa)	10.3 (GPa)
Compressive Strength	429 (MPa)	426 (MPa)

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. This is a material science study, not a clinical study on a test set for an AI device.

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):
Not applicable. This is a material science study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. This is a material science 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:
Not applicable. This is a material science study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a material science study.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" here would be laboratory measurements of physical and mechanical properties.

8. The sample size for the training set:
Not applicable. This is a material science study, not an AI training process.

9. How the ground truth for the training set was established:
Not applicable. This is a material science study.

Summary of what the document does indicate about the study:

Study Type: Non-clinical (benchtop) performance and biocompatibility testing of a dental restorative material.
Standards Used: ISO 4049 (Polymer-based Restorative Materials), ISO 7405 (Biocompatibility of medical devices in dentistry), ISO 10993-1 (Biological Evaluation of Medical Devices).
Performance Metrics: Flexural strength, flexural modulus, compressive strength, and biocompatibility.
Conclusion: The subject device (BRILLIANT Crios) "passed all required testing" and was determined to be "as safe and effective as the predicate device" based on these tests.

Summary

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August 15, 2018

Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is in blue and consists of the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" stacked on top of each other.

Coltene/Whaledent AG % Stuart Goldman Senior Consultant Emergo Global Consulting. LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, Texas 78746

Re: K181500

Trade/Device Name: BRILLIANT Crios Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: June 1, 2018 Received: June 7, 2018

Dear Stuart Goldman:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Mary S. Runner -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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Indications for Use

510(k) Number (if known) K181500

Device Name BRILLIANT Crios

Indications for Use (Describe) BRILLIANT Crios is indicated for:

Crowns, inlays, onlays and veneers
Implant-supported crowns

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

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

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510(k) Summary

K181500

BRILLIANT Crios

1. Submission Sponsor

Coltène/Whaledent AG Feldwiesenstrasse 20 Altstätten Sankt Gallen 9450 Switzerland

Contact: Dr. Daniel Meier Title: Manager Regulatory Affairs Phone: 41 71 757 5852

2. Submission Correspondent

Emergo Global Consulting, LLC 2500 Bee Cave Road Building 1, Suite 300 Austin, TX 78746

Contact: Stuart R. Goldman Title: Senior Consultant RA/QA Phone: (512) 327-9997

3. Date Prepared

June 1, 2018

4. Device Identification

Trade Name:	BRILLIANT Crios
Common Name:	Restorative resin material
Classification Name:	Tooth shade resin material
Regulation Number:	872.3690
Product Code:	EBF
Class:	Class II
Classification Panel:	Dental

5. Legally Marketed Predicate Device(s)

CERASMART™ (K133824); Manufacturer: GC America, Inc. ●
. Coltène/Whaledent AG is also using their own device, SYNERGY® (K974465) as a ReferenceDevice.

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6. Indication for Use

BRILLIANT Crios is indicated for:

Crowns, inlays, onlays and veneers
Implant-supported crowns.

7. Device Overview

8. Substantial Equivalence Discussion

Table 5-1 compares BRILLIANT Crios blocks to the predicate device with respect to its physical state, structure, materials, mechanical properties, indications for use, packaging, biocompatibility and performance testing, and provides detailed information regarding the basis for the determination of substantial equivalence. The reference device is also included in this table for comparative purposes.

Attributes	ReferenceDevice	Predicate Device	Subject Device	Similarities /Differences
Device Name	SYNERGY®	CERASMART™	BRILLIANT Crios	-
Manufacturer	Coltène/Whaledent	GC America	Coltène/Whaledent	-
510(k) #	K974465	K133824	Pending	-
Product Code	EBF	EBF	EBF	Same
Regulation	§872.3690	§872.3690	§872.3690	Same
Class	II	II	II	Same
Review Panel	Dental	Dental	Dental	Same
Device Image	Image: SYNERGY®	Image: CERASMART™	Image: BRILLIANT Crios	-
Indications forUse	SYNERGY isindicated for:- direct filling ofclass I, II, III, IVand V cavities,- reconstruction	The product isindicated for inlays,onlays, veneers andfull crownrestorations,including crowns on	BRILLIANT Crios isindicated for:- Crowns, inlays, onlaysand veneers- Implant-supportedcrowns	The subject andpredicate device havethe same intendeduse and are used forpermanent toothrestorations.
Attributes	ReferenceDevice	Predicate Device	Subject Device	K#####Similarities /Differences
	of naturalenamel anddentine,reconstructionof fracturedanteriors, sealing ofextendedfissures inmolars andpremolars, stabilization ofmobileanteriors, repair ofveneer facings, fixation ofsplints, bondedbridges, esthetic	implants
Physical State	Viscous paste	Cured blocks	Cured blocks	The subject andpredicate device aresupplied as curedblocks and CAD/CAMmilled into the finaldental restoration.
Structure	Polymer resincomposite	Polymer resin /ceramic hybridcomposite	Polymer resincomposite	The subject devicehas an all polymerresin matrix while thepredicate device hasa polymer resin /ceramic hybridmatrix.
Resin MatrixMonomers	Bis-GMA, Bis-EMA,TEGDMA	Bis-MEPP, UDMA,DMA	Bis-GMA, Bis-EMA,TEGDMA, UDMA	The subject andpredicate device bothcontain UDMA intheir resin matrix.
Filler	Silica, barium glass	Silica, barium glass	Silica, barium glass	Same
Sizes	na	12, 14 and 14L	12, 14	The subject devicesize ranges fall within
Attributes	Reference Device	Predicate Device	Subject Device	Similarities / Differences
Flexural Strength	125 (MPa)	160 (MPa)	198 (MPa)	those of thepredicate device.
Flexural Modulus of	6.8 (GPa)	8.3 (GPa)	10.3 (GPa)	Similar
Compressive Strength	390 (MPa)	429 (MPa)	426 (MPa)	Similar
Packaging	Plunger syringe type (2.3 g)	Mandrel mounted; five to a box	Mandrel mounted; five to a box	The subject and predicate device are packaged the same way based on their physical state.
Usage	Single Patient, multiple use	Single Patient, multiple use	Single Patient, multiple use	Same
Sterility	Non-Sterile	Non-Sterile	Non-Sterile	Same
Biocompatibility	Conforms with ISO 10993-1	Conforms with ISO 10993-1	Conforms with ISO 10993-1	Same
Performance	Conforms with ISO 4049	Conforms with ISO 4049	Conforms with ISO 4049	Same

Table 5-1 - Comparison of Device Characteristics

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9. Non-Clinical Performance Data

As part of demonstrating substantial equivalence of BRILLIANT Crios blocks to the predicate device, Coltène/Whaledent submitted final finished devices for extensive testing in accordance with the applicable parts of the following voluntary standards, as well as to the company's own internal test protocols:

. ISO 4049, Dentistry – Polymer-based Restorative Materials
ISO 7405, Dentistry Evaluation of biocompatibility of medical devices used indentistry .
. ISO 10993-1, Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process

Testing evaluated flexural strength, flexural modulus, compressive strength, and biocompatibility of the subject device, as well as other related physical properties. The subject device passed all required testing.

10. Statement of Substantial Equivalence

BRILLIANT Crios blocks have the same intended use, indications for use, physical attributes, and are fabricated into permanent tooth restorations using the same CAD/CAM manufacturing methods as CERASMART™ blocks. Any minor differences in the materials used to make the subject device when compared to the predicate device have been successfully evaluated by Coltène/Whaledent through extensive performance and biocompatibility testing on their device, such that the information submitted to the FDA demonstrates that the subject device is as safe and effective as the predicate device and

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does not raise any new questions of safety and effectiveness. BRILLIANT Crios blocks, as designed and manufactured by Coltène/Whaledent, have been determined to be substantially equivalent to CERASMART™ blocks.

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.