BRILLIANT Crios

K181500 · Coltene/Whaledent AG · EBF · Aug 15, 2018 · Dental

Device Facts

• Record ID: K181500
• Device Name: BRILLIANT Crios
• Applicant: Coltene/Whaledent AG
• Product Code: EBF · Dental
• Decision Date: Aug 15, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

BRILLIANT Crios is indicated for: - Crowns, inlays, onlays and veneers - Implant-supported crowns

Device Story

BRILLIANT Crios is a radiopaque composite material consisting of crosslinked methacrylate-based polymerized monomers and dental glass fillers. Supplied as cured blocks in various sizes, shades, and translucencies; intended for fabrication of permanent tooth restorations (crowns, inlays, onlays, veneers, implant-supported crowns) using CAD/CAM milling equipment. Used in dental clinics by dental professionals. The material is milled into the final restoration shape; provides a durable, tooth-colored restorative solution for patients requiring dental reconstruction.

Clinical Evidence

Bench testing only. No clinical data. Testing included flexural strength, flexural modulus, compressive strength, and biocompatibility per ISO 4049, ISO 7405, and ISO 10993-1. Results confirmed the device meets performance requirements.

Technological Characteristics

Radiopaque composite material; crosslinked methacrylate-based monomers (Bis-GMA, Bis-EMA, TEGDMA, UDMA) and silica/barium glass fillers. Supplied as cured blocks for CAD/CAM milling. Non-sterile. Conforms to ISO 4049 (polymer-based restorative materials) and ISO 10993-1 (biocompatibility).

Indications for Use

Indicated for permanent tooth restorations including crowns, inlays, onlays, veneers, and implant-supported crowns.

Regulatory Classification

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.

Predicate Devices

• CERASMART™ (K133824)

Reference Devices

• SYNERGY® (K974465)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

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: [phone]

#### 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: [phone]

#### 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

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.

#### 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 | Reference<br>Device | Predicate Device | Subject Device | Similarities /<br>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 for<br>Use | SYNERGY is<br>indicated for:<br>- direct filling of<br>class I, II, III, IV<br>and V cavities,<br>- reconstruction | The product is<br>indicated for inlays,<br>onlays, veneers and<br>full crown<br>restorations,<br>including crowns on | BRILLIANT Crios is<br>indicated for:<br>- Crowns, inlays, onlays<br>and veneers<br>- Implant-supported<br>crowns | The subject and<br>predicate device have<br>the same intended<br>use and are used for<br>permanent tooth<br>restorations. |
| Attributes | Reference<br>Device | Predicate Device | Subject Device | K#####<br>Similarities /<br>Differences |
| | of natural<br>enamel and<br>dentine,<br>reconstruction<br>of fractured<br>anteriors, sealing of<br>extended<br>fissures in<br>molars and<br>premolars, stabilization of<br>mobile<br>anteriors, repair of<br>veneer facings, fixation of<br>splints, bonded<br>bridges, esthetic | implants | | |
| Physical State | Viscous paste | Cured blocks | Cured blocks | The subject and<br>predicate device are<br>supplied as cured<br>blocks and CAD/CAM<br>milled into the final<br>dental restoration. |
| Structure | Polymer resin<br>composite | Polymer resin /<br>ceramic hybrid<br>composite | Polymer resin<br>composite | The subject device<br>has an all polymer<br>resin matrix while the<br>predicate device has<br>a polymer resin /<br>ceramic hybrid<br>matrix. |
| Resin Matrix<br>Monomers | Bis-GMA, Bis-EMA,<br>TEGDMA | Bis-MEPP, UDMA,<br>DMA | Bis-GMA, Bis-EMA,<br>TEGDMA, UDMA | The subject and<br>predicate device both<br>contain UDMA in<br>their resin matrix. |
| Filler | Silica, barium glass | Silica, barium glass | Silica, barium glass | Same |
| Sizes | na | 12, 14 and 14L | 12, 14 | The subject device<br>size ranges fall within |
| Attributes | Reference Device | Predicate Device | Subject Device | Similarities / Differences |
| Flexural Strength | 125 (MPa) | 160 (MPa) | 198 (MPa) | those of the<br>predicate 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.