(259 days)
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No
The 510(k) summary describes a dental porcelain material system and its components, with no mention of software, algorithms, or any technology related to AI or ML. The performance studies focus on material properties.
No
This device is a dental porcelain material used to construct dental prosthetics (crowns, bridges, veneers), not to treat or cure a disease or condition. It is a restorative material, not a therapeutic agent.
No
The device is a dental porcelain material used for constructing crowns, bridges, and veneers. It is a material used in the creation of dental prosthetics, not for diagnosing any condition.
No
The device description clearly states it is a dental porcelain material system consisting of various physical components like powders, liquids, and ingots, which are hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to be used in the construction of dental prosthetics (crowns, bridges, veneers) for individual dental patients. This is a restorative and prosthetic application, not a diagnostic one.
- Device Description: The device is a dental porcelain material used by dental technicians to create physical dental prosthetics. It is applied to a framework and then fired to create the final restoration. This process is entirely external to the patient's body and does not involve analyzing biological samples for diagnostic purposes.
- Lack of Diagnostic Activity: There is no mention of the device being used to test, analyze, or diagnose any condition or characteristic of the patient's body or biological samples.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Life Essence Universal Porcelain System does not perform any such function.
N/A
Intended Use / Indications for Use
The Life Essence Universal Porcelain System is a dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
Product codes
EIH
Device Description
Life Essence Universal Porcelain is dental porcelain used by dental technicians to create crowns, bridges, and veneers. It consists of three categories: low fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Pastes, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Spray Glaze, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
dental technicians
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench testing (according to ISO 6872:2008 Dentistry-Ceramic Materials) to determine flexural strength, solubility and glass transition temperature was provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is a stylized symbol that resembles three human profiles facing to the right, stacked on top of each other. The profiles are connected and form a wing-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 4, 2017
Blue Sky Bio % Angela Blackwell Senior Consultant Blackwell Device Consulting 888 E. Belvedere Rd., Suite 212 Grayslake, Illinois 60030
Re: K163251
Trade/Device Name: Life Essence Universal Porcelain System Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 27, 2017 Received: July 5, 2017
Dear Angela Blackwell:
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.
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
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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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (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 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Andrew I. Steen -S
for Lori Wiggins, MPT, CLT 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K163251
Device Name
Life Essence Universal Porcelain System
Indications for Use (Describe)
The Life Essence Universal Porcelain System is a dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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510(k) Summary
Life Essence Universal Porcelain System
Blue Sky Bio LLC 888 E Belvidere Rd Suite 212 Grayslake. IL 60030
718-376-0422
www.blueskybio.com
Contact Person: Albert Zickmann
Date Prepared: August 4, 2017
| General Information | |
|---|---|
| Trade Name | Life Essence Universal Porcelain System |
| Common Name | Porcelain powder for dental use |
| Predicate 510(k) | Luminesse Porcelain K140848 |
| Product Code | EIH |
| Regulation No. | 872.6660 Porcelain Powder for Clinical Use |
| Classification | Class II |
Device Description:
Life Essence Universal Porcelain is dental porcelain used by dental technicians to create crowns, bridges, and veneers. It consists of three categories: low fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Pastes, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Spray Glaze, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.
Indications for Use:
The Life Essence Universal Porcelain System is a dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
Primary Predicate Indications for Use:
The Luminesse Porcelain System is a dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.
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Technological Characteristics:
Life Essence Universal Porcelain is used to veneer or press over the appropriate base materials (metal or zirconia). In order to prevent cracking and avoid damage of the restoration due to the thermally-induced stress, the average coefficient of thermal expansion has been adjusted to a coefficient of thermal expansion of the appropriate base materials, which allows fusion to the base materials. This is the main technological characteristic of the dental porcelains in general, and it is shared by the subject device and predicate device. Bench testing (according to ISO 6872:2008 Dentistry-Ceramic Materials) to determine flexural strength, solubility and glass transition temperature was provided. See tables below for the specific product types and what class they are according to the standard.
| Class | Dental Powder | Life Essence Low-Fusing Porcelain Powder |
|---|---|---|
| 1 | Core ceramic powder | Opaque Powder, Dentin Modifier |
| 2 | Dentin | Dentin Powder, Opacious Dentin |
| 3 | Enamel | Incisal |
| 4 | Neck material | Margin |
| 5 | Transparent Material | Incisal Translucent |
| 6 | Stains | Universal Stain Shades |
| 7 | Add-on material | Correction Powder |
| 8 | Glaze materials | Universal Glaze |
| Type 2, | Core ceramic powder | Pressable Pellets |
| class 1 |
| Class | Dental Powder | Life Essence High-Fusing Porcelain Powder |
|---|---|---|
| 1 | Core ceramic powder | Opaque Powder |
| 1.1 | Core ceramic paste | Opaque Paste |
| 2 | Dentin | Dentin Powder |
| 2.1 | Dentin Modifier | Opacious Dentin, Dentin Modifier, Gingival |
| 3 | Enamel | Incisal |
| 4 | Neck Material | Margin, Neck Translucent |
| 5 | Transparent material | Incisal Translucent |
| 6 | Stains | Universal Stain Shades |
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| 7 | Add-on material | Correction Powder |
|---|---|---|
| 8 | Glaze materials | Universal Glaze |
| Class | Dental Powder | Life Essence Zirconia Porcelain Powder |
|---|---|---|
| 1 | Core ceramic powder | Dentin Modifier |
| 2 | Dentin | Dentin Powder, Gingival |
| 3 | Enamel | Incisal |
| 4 | Neck material | Margin, Neck Translucent |
| 5 | Transparent Material | Opal Translucent, Incisal Translucent |
| 6 | Stains | Universal Stain Shades |
| 7 | Add-on material | Correction Powder |
| 8 | Glaze materials | Universal Glaze |
Conclusion:
All components found in Life Essence Universal Porcelain are identical to components in the predicate device system. It has the same technological characteristics, chemical composition, manufacturing process, and same indications for use as the predicate devices. Components of this product have not changed in any way from the predicate that would adversely affect biocompatibility; therefore, it is determined that no biocompatibility testing is necessary for this product.
Life Essence Universal Porcelain, as designed and manufactured, is substantially equivalent to the predicate device in terms of indications for use, chemical composition, manufacturing and technological characteristics.