(196 days)
Not Found
No
The description focuses on the material composition and physical properties of the dental restorative material, not on any software or analytical capabilities that would typically involve AI/ML. There are no mentions of AI, ML, image processing, or data analysis in the provided text.
No
The device is a material for dental restorations (inlays, onlays, veneers, crowns, and bridges), not a device that itself provides therapy.
No
Explanation: The device is described as a material for dental restorations (inlays, onlays, veneers, crowns, and bridges) that is milled into its restorative form. It does not perform any diagnostic function.
No
The device description clearly states it is a "solid block of material" and is "milled in a dental CAD/CAM machine," indicating it is a physical material and not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (inlays, onlays, veneers, crowns, and bridges). This is a therapeutic and restorative purpose, not a diagnostic one.
- Device Description: The device is a material block used for milling dental prosthetics. It's a physical material, not a test or reagent used to examine specimens from the human body.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting diseases, or providing diagnostic information.
- Performance Studies: The performance studies focus on the physical properties and durability of the material for its intended restorative use, not on diagnostic accuracy.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.
Product codes
EIH, EBF
Device Description
The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks of glass ceramic and polymer material to form a solid block of material. The unique marriage of the two materials creates a dual-network hybrid, which lends the positive physical properties of each individual material to the other. This results in a material with significantly lower brittleness compared to a pure ceramic and better abrasion behavior than a pure resin, (similar to natural enamel). The material is milled in a dental CAD/CAM machine into its restorative form.
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 professional
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)
Bench testing was performed on Crystal® Ultra in accordance to FDA recognized standards and compared to predicate devices as per ISO 6872, ISO 10477, ISO 10993, ISO 4049, and ISO 7405, including bench testing and comparative analysis of flexural strength, chemical solubility, elasticity, compressive strength, density, water absorption, shade stability, color consistency, and water solubility. The results of this testing allowed us to conclude that Crystal® Ultra is substantially equivalent in safety (and effectiveness) to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
K130654
510(k) Summary
Image /page/0/Picture/2 description: The image is a black and white logo that is divided into four quadrants. The letters "DL" are in the top two quadrants, and the letters "MS" are in the bottom two quadrants. The letters are in a bold, sans-serif font. The logo is circular in shape.
Dental Laboratory Milling Supplies
| Submitter | Dental Laboratory Milling Supplies, LLC (DLMS)
14201 N 87th Street #A-105, Scottsdale, AZ 85260 | |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------|
| Contact | Scott Atkin, President, 480-948-0466
email: scott@dentalzirconia.com | |
| 510(k) Number | K130654 | SEP 2 4 2013 |
| Date Prepared | Revised on September 9, 2013
Original submitted on Feb 11, 2013 | |
| Trade/Device Name | Crystal® Ultra | |
| Common Name | Dental CAD/CAM Material | |
| Classification Names | Porcelain Powder for Clinical Use (21 CFR 872.6660, Product Code EIH)
Tooth Shade Resin Material (21 CFR 872.3690, Product Code: EBF) | |
| Predicate Device(s) | "Lava Ultimate CAD/CAM Restorative for CEREC/ E4D, Lava Ultimate Implant Crown
Restorative," K110131, dated 1/21/11, and Vita "Enamic," K122269, dated 12/13/12 | |
| Device Description | The Crystal® Ultra CAD/CAM formed materials consist of interpenetrating networks
of glass ceramic and polymer material to form a solid block of material. The unique
marriage of the two materials creates a dual-network hybrid, which lends the positive
physical properties of each individual material to the other. This results in a material
with significantly lower brittleness compared to a pure ceramic and better abrasion
behavior than a pure resin, (similar to natural enamel). The material is milled in a
dental CAD/CAM machine into its restorative form. | |
| Statement of Intended Use | Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays,
veneers, crowns, and bridges. | |
| Substantial Equivalence | Information provided in this application shows that the product is substantially
equivalent to the predicate devices. Both Crystal® Ultra and the predicate devices
are composite ceramic and resin materials. The blending of these two proven dental
materials creates beneficial physical properties while remaining compliant to the FDA
recognized consensus standards applied to these material types. Bench testing was
performed on Crystal® Ultra in accordance to FDA recognized standards and
compared to predicate devices as per ISO 6872, ISO 10477, ISO 10993, ISO 4049,
and ISO 7405, including bench testing and comparative analysis of flexural strength,
chemical solubility, elasticity, compressive strength, density, water absorption, shade
stability, color consistency, and water solubility. Comparisons of the physical
properties of the Crystal® Ultra to the predicate devices are included in this
application, which illustrate that they are substantially equivalent. | |
| Design Characteristics | The geometry of the Crystal® Ultra material is shaped into block or disc forms as
defined by the CAD/CAM manufacturer. The material will be inserted in to the CAM
machine and milled into its final form, then polished and ready for placement
thereafter. | |
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- Material Characteristics .......... The majority volume of the Crystal® Ultra material is made up of a ceramic material similar to the predicate devices and used commonly in dentistry. The remaining volume of the block is made up of resin. This combination of ceramic and resin material is similar to the Vita Enamic and Lava Ultimate predicates. Comparisons of the material composition to the two predicates to the Crystal® Ultra are included in this application.
- Biocompatibility ............................................................................................................................................................. FDA Recognized ISO 10933 standards. This assessment, included in this application, concluded that the device substantially equivalent in safety (and effectiveness) to the predicate device.
- Non-Clinical Performance Data. Bench testing was performed in accordance to FDA recognized standards ISO 6872, ISO 10477, ISO 7405, and ISO 4049 which includes ISO testing of flexural strength, solubility, radioactivity, storage stability, color stability, color consistency, plus additional evaluation of bond strength, modulus of elasticity and compressive strength. The results of this testing allowed us to conclude that Crystal® Ultra is substantially equivalent in safety (and effectiveness) to the predicate device. Test results are included in this application.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract shapes resembling birds in flight, stacked on top of each other.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 24, 2013
Dental Laboratory Milling Supplies, L.L.C. C/O Mr. Scott Atkin President 14201 North 87th Street. Suite A-101 Scottsdate, AZ 85260
Re: K130654
Trade/Device Name: Crystal® Ultra Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Codes: EIH, EBF Dated: August 20, 2013 Received: August 26, 2013
Dear Mr. Atkin:
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.
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Page 2 - Mr. Mr. Atkin
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 Acc 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 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industrv/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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/Reportal"roblem/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 Small Manufacturers, International and Consumer Assistance 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.
Sincercly yours.
Richard C. Chapman
for
Kwame Ulmer M.S. Acting Division 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 Statement
510(k) Number (if known): K130654
Device Name: Crystal Uitra
Indications for Use:
Crystal® Ultra is indicated for use as a dental restoration including inlays, onlays, veneers, crowns and bridges.
For use by or on the order of a dental professional.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)
Andrew I. Steen 2013.09.24 11:35:48 -04'00'
(Division Sign-O11) swiston of Anesthastology, General Heaptel ntection Control, Dental Devices
510(k) Number K130654
Dental Laboratory Milling Supplies, 14201 N 87th St #A-101, Scottsdale, AZ 85260