(69 days)
No
The description focuses on the material composition and physical properties of the dental restoration block, with no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is a material (composite) used for fabricating permanent tooth restorations, not a device that directly provides therapy or treatment.
No
The device is described as a material for fabricating permanent tooth restorations and its intended use is for crowns, inlays, onlays, and veneers. This indicates it is a therapeutic or restorative device, not a diagnostic one.
No
The device description clearly states it is a "radiopaque composite material" in "block forms," indicating it is a physical material, not software.
Based on the provided information, BRILLIANT Crios is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for fabricating permanent tooth restorations (crowns, inlays, onlays, veneers, implant-supported crowns). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a composite material used for milling dental prosthetics. It's a material used in the body, not a reagent or instrument used to test samples from the body.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (blood, urine, tissue, etc.) or provide diagnostic information about a patient's health condition.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. BRILLIANT Crios does not fit this description.
N/A
Intended Use / Indications for Use
BRILLIANT Crios is indicated for:
- Crowns, inlays, onlays and veneers
- Implant-supported crowns.
Product codes
EBF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tooth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 indolentistry .
- . 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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
2
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)
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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
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.
4
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
Device | 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 for
Use | SYNERGY is
indicated for:
- direct filling of
class I, II, III, IV
and V cavities, - reconstruction | The product is
indicated for inlays,
onlays, veneers and
full crown
restorations,
including crowns on | BRILLIANT Crios is
indicated for: - Crowns, inlays, onlays
and veneers - Implant-supported
crowns | The subject and
predicate device have
the same intended
use and are used for
permanent tooth
restorations. |
| Attributes | Reference
Device | Predicate Device | Subject Device | K#####
Similarities /
Differences |
| | of natural
enamel and
dentine,
reconstruction
of fractured
anteriors, sealing of
extended
fissures in
molars and
premolars, stabilization of
mobile
anteriors, repair of
veneer facings, fixation of
splints, bonded
bridges, esthetic | implants | | |
| Physical State | Viscous paste | Cured blocks | Cured blocks | The subject and
predicate device are
supplied as cured
blocks and CAD/CAM
milled into the final
dental restoration. |
| Structure | Polymer resin
composite | Polymer resin /
ceramic hybrid
composite | Polymer resin
composite | The subject device
has an all polymer
resin matrix while the
predicate device has
a polymer resin /
ceramic hybrid
matrix. |
| Resin Matrix
Monomers | Bis-GMA, Bis-EMA,
TEGDMA | Bis-MEPP, UDMA,
DMA | Bis-GMA, Bis-EMA,
TEGDMA, UDMA | The subject and
predicate device both
contain UDMA in
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
size ranges fall within |
| Attributes | Reference Device | Predicate Device | Subject Device | Similarities / Differences |
| Flexural Strength | 125 (MPa) | 160 (MPa) | 198 (MPa) | those of the
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
5
6
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
7
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.