(89 days)
Not Found
No
The device is a coloring liquid for dental restorations and the description focuses on its chemical and physical properties, not software or algorithmic functions. There is no mention of AI, ML, or any related concepts in the document.
No
Explanation: The device is a coloring liquid used to enhance the esthetic properties of zirconia restorations, and it is applied before sintering. It is not intended to treat or diagnose any disease or condition. Its purpose is solely for the fabrication of dental restoration materials.
No
This device is a coloring liquid used for dental restorations, not for diagnosing any medical condition.
No
The device is a liquid solution used for coloring zirconia restorations, which is a physical substance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for coloring pre-sintered zirconia structures" for the fabrication of dental restorations. This is a manufacturing process for a medical device (the dental restoration), not a diagnostic test performed on a biological sample.
- Device Description: The description details a set of solutions used to enhance the esthetic properties of zirconia restorations by applying them to the structure before sintering. This is a material used in the creation of a medical device.
- Lack of Diagnostic Purpose: There is no mention of the device being used to diagnose, monitor, or treat any disease or condition by examining a biological sample.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
BruxZir™ Opaque Coloring Liquid is used for coloring pre-sintered zirconia structures.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
BruxZir™ Opaque Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C.
BruxZir™ Opaque Coloring Liquid is available in different colors, Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental technicians
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)
Non-clinical data submitted to demonstrate substantial equivalence include:
- Mechanical testing for flexural strength and solubility
- Visual shade evaluation
- Shelf life
- Packaging validation
- Biocompatibility
No clinical data is included in this submission.
Flexural Strength:
Flexural strength testing was performed on the zirconia substrate treated with the subject device, BruxZir™ Opaque Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results of the testing demonstrated that the subject device does not significantly affect the mechanical property of zirconia substrate. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Solubility:
Chemical solubility was tested on the worst case, which is the zirconia substrate with all 5 shades of the subject device, BruxZir™ Opaque Coloring Liquid applied. It was concluded that the solubility is below 100 ug/cm2 limit, meeting the ISO 6872:2015/ Amd 1:2018 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Visual Shade Evaluation:
The dental restorations were milled from the zirconia milling blanks with application of the subject device, BruxZir™ Opaque Coloring Liquid. Visual shade evaluations were performed on the sintered and glazed restorations by qualified reviewers against the reference shade guides. It was concluded that BruxZir™ Opaque Coloring Liquid meets shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Shelf Life:
The accelerated aging test was performed per ASTM F1980-16 in order to establish the shelf life of the subject device, BruxZir™ Opaque Coloring Liquid. It was concluded that the shelf life of BruxZir™ Opaque Coloring Liquid is 2 years. The results of the testing were used to address questions related to substantial equivalence based on differences in shelf life between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Packaging Validation:
Packaging validation was performed on the subject device, BruxZir™ Opaque Coloring Liquid. Per ASTM D4169-16, the shipping unit was tested for manual handling drops, vehicle stacking, loose load vibration, low pressure hazard, vehicle vibration and concentrated impact. Following distribution simulation testing, the packaging contents were visually inspected for signs of damages, or leaks. Visual examination of the parts did not reveal any damage of the packaged contents and any leaks of the coloring liquids and revealed that the seal of the bottles was intact. The results of the testing were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Biocompatibility:
The subject device, BruxZir™ Opaque Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation, BruxZir™ Opaque Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010) and Oral Mucosal Irritation (ISO 10993-10:2010) to meet the biocompatibility requirements. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
June 29, 2022
Prismatik Dentalcraft, Inc. So Park Regulatory Affairs Manager 2144 Michelson Drive Irvine, California 92612
Re: K220960
Trade/Device Name: BruxZir Opaque Coloring Liquid Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: March 31, 2022 Received: April 1, 2022
Dear So Park:
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name BruxZir™ Opaque Coloring Liquid
Indications for Use (Describe)
BruxZir™ Opaque Coloring Liquid is used for coloring pre-sintered zirconia structures.
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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3
Image /page/3/Picture/0 description: The image contains the logo for Prismatik Dentalcraft, Inc. On the left side of the logo is a triangle with different colors. To the right of the triangle is the text "PRISMATIK DENTALCRAFT, INC." The text is in a sans-serif font and is blue.
K220960 510(k) Summary
I. SUBMITTER
Prismatik Dentalcraft, Inc. 2144 Michelson Drive. Irvine, CA 92612, USA
Primary Contact Person: So Hyun Park, Regulatory Affairs Manager, MS Email: so.park@glidewelldental.com Phone: (949) 863-5479
Secondary Contact Person: Herbert Crane, VP RA/OA Email: Herbert.Crane@glidewelldental.com Phone: (949) 222-3531
Date Prepared: June 24, 2022
DEVICE II.
Name of Device: BruxZir™ Opaque Coloring Liquid Common Name or Usual Name: Liquid for Dental Zirconia Prosthesis Classification Name: Porcelain powder for clinical use (21 CFR 872.6660) Regulatory Class: Class II Product Code: EIH
III. PRIMARY PREDICATE DEVICE
Zirkonzahn COLOUR LIQUID (K190518)
DEVICE DESCRIPTION IV.
BruxZir™ Opaque Coloring Liquid comprises a set of solutions that enhance the esthetic properties of zirconia restorations. The solution is applied to the zirconia restorations before sintering, by dipping the framework into the liquid or by using a metal-free brush. Afterwards, the structure is dried and subsequently sintered at temperatures above 1400°C.
BruxZir™ Opaque Coloring Liquid is available in different colors, Opaq-Lite, Opaq-A, Opaq-C, Opaq, Opaq Plus. The devices are intended to be used solely by dental technicians for fabrication of zirconia restorations for individual dental patients.
4
Image /page/4/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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
V. INDICATIONS FOR USE
BruxZir™ Opaque Coloring Liquid is used for coloring pre-sintered zirconia structures.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
| Technological
Characteristics | Subject Device
(TBD) | Predicate Device
(K190518) | Comparison | |
|----------------------------------|--------------------------------------|--------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------|------------------------------------|
| Design
Characteristics | Device Name | BruxZirTM Opaque
Coloring Liquid | Zirkonzahn COLOUR
LIQUID | N/A |
| | Product Code | EIH | EIH | Same |
| | Manufacturer | Prismatik Dentalcraft, Inc. | ZIRKONZAHN SRL | N/A |
| | Intended Use/
Indications for Use | BruxZirTM Opaque
Coloring Liquid is used
for coloring pre-sintered
zirconia structures. | Zirkonzahn COLOUR
LIQUID is used for
coloring pre-sintered
zirconia structures. | Same except for the
device name |
| | Prescription Device | Yes | Yes | Same |
| | Chemical
Composition | Aqueous solutions of
transition and lanthanide
metal salts | Aqueous solutions of
transition and lanthanide
metal salts | Similar |
| | Biocompatibility | Biocompatible | Biocompatible | Same |
| | Principles of
Operation | Brushing or Dipping
Technique | Brushing or Dipping
Technique | Same |
| | Type of Packaging
and Volume | Bottle; 175mL | Bottle; 20mL, 50mL,
100mL | Similar |
| | Shade | Various; Opaq-Lite,
Opaq-A, Opaq-C, Opaq,
Opaq Plus | Various; A1-D4 | Similar |
| | Sterility | Non-sterile | Non-sterile | Same |
DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The subject device, BruxZir™ Opaque Coloring Liquid, is substantially equivalent in intended use, material, design principles and performance to the predicate device, Zirkonzahn COLOUR LIQUID (K190518). The intended use/indications for use for both the subject device and the predicate device are the same except for the device name. Both devices are liquids used for coloring pre-sintered zirconia restorations. The fundamental principle of operation of the subject device and the predicate device is same. The subject device and the predicate device are similar in terms of chemical composition as both devices contain transition and lanthanide metals as the major constituents.
5
Image /page/5/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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
The substantial equivalence comparison table above outlines and provides the similarities between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518). Both the subject device and the predicate device have similar physical/mechanical and biocompatibility properties that met the requirements of ISO 6872:2015/Amd 1:2018 and ISO 10993. And differences between the subject device and the predicate device do not raise any new concerns of safety and effectiveness.
VII. PERFORMANCE DATA
Non-clinical data submitted to demonstrate substantial equivalence include:
- Mechanical testing for flexural strength and solubility ●
- Vishal shade evaluation
- Shelf life
- Packaging validation .
- Biocompatibility
No clinical data is included in this submission.
Flexural Strength
Flexural strength testing was performed on the zirconia substrate treated with the subject device, BruxZir™ Opaque Coloring Liquid, per ISO 6872:2015/Amd 1:2018. The results of the testing demonstrated that the subject device does not significantly affect the mechanical property of zirconia substrate. The results of the testing were used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Solubility
Chemical solubility was tested on the worst case, which is the zirconia substrate with all 5 shades of the subject device, BruxZir"™ Opaque Coloring Liquid applied. It was concluded that the solubility is below 100 ug/cm2 limit, meeting the ISO 6872:2015/ Amd 1:2018 requirement. The result of the testing was used to address questions related to substantial equivalence based on differences in device design between the subject device, BruxZirTM Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Visual Shade Evaluation
The dental restorations were milled from the zirconia milling blanks with application of the subject device, BruxZir™ Opaque Coloring Liquid. Visual shade evaluations were performed on the sintered and glazed restorations by qualified reviewers against the reference shade guides. It was concluded that BruxZir"M Opaque Coloring Liquid meets shade match requirements and works as intended. The results of the testing were used to address questions related to substantial equivalence based on differences in
6
Image /page/6/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 blue, with "PRISMATIK" on the top line and "DENTALCRAFT, INC." on the bottom line.
device design between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Shelf Life
The accelerated aging test was performed per ASTM F1980-16 in order to establish the shelf life of the subject device, BruxZir™ Opaque Coloring Liquid. It was concluded that the shelf life of BruxZir™ Opaque Coloring Liquid is 2 years. The results of the testing were used to address questions related to substantial equivalence based on differences in shelf life between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Packaging Validation
Packaging validation was performed on the subject device, BruxZir1M Opaque Coloring Liquid. Per ASTM D4169-16, the shipping unit was tested for manual handling drops, vehicle stacking, loose load vibration, low pressure hazard, vehicle vibration and concentrated impact. Following distribution simulation testing, the packaging contents were visually inspected for signs of damages, or leaks. Visual examination of the parts did not reveal any damage of the packaged contents and any leaks of the coloring liquids and revealed that the seal of the bottles was intact. The results of the testing were used to address questions related to substantial equivalence based on differences in packaging configuration between the subject device, BruxZir™ Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
Biocompatibility
The subject device, BruxZir™ Opaque Coloring Liquid, was tested in accordance with ISO 10993-1. Per the biological evaluation, BruxZir™ Opaque Coloring Liquid was tested for Cytotoxicity (ISO 10993-5:2009), Sensitization (ISO 10993-10:2010) and Oral Mucosal Irritation (ISO 10993-10:2010) to meet the biocompatibility requirements. Based on the biocompatibility testing results, it was determined that there is no biocompatibility concern for the subject device. The results of the testing were used to address questions related to substantial equivalence based on differences in chemical composition between the subject device, BruxZir"M Opaque Coloring Liquid, and the predicate device, Zirkonzahn COLOUR LIQUID (K190518).
VIII. CONCLUSION
Based on the technological characteristics and non-clinical test data included in this submission, the subject device, BruxZir"M Opaque Coloring Liquid, has been shown to be substantially equivalent to the primary predicate device, Zirkonzahn COLOUR LIQUID (K190518).