(306 days)
Not Found
No
The description focuses on the material properties and manufacturing process (CAD/CAM) of the ceramic discs, with no mention of AI or ML in the device itself or its intended use.
No
This device is a material used for fabricating restorations, not a device that directly provides therapy.
No
The device is described as a material for fabricating dental restorations (copings, crowns, bridges, inlays, and onlays), not for diagnosing medical conditions. It is a material for treatment, not diagnosis.
No
The device description clearly states it is a zirconium dioxide-yttrium oxide ceramic material pressed into pre-sintered discs, which is a physical material, 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 the fabrication of dental restorations (copings, crowns, bridges, inlays, onlays) for anterior and posterior segments. This is a structural and restorative purpose, not a diagnostic one.
- Device Description: The device is a ceramic material used for creating physical dental prostheses. It is processed using CAD/CAM technology and cemented into place by a dentist. This describes a material used in a restorative procedure, not a test performed on a biological sample to diagnose a condition.
- Lack of Diagnostic Elements: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.
- Performance Studies: The performance studies focus on physical characteristics like flexural strength and solubility, which are relevant to the material's structural integrity and durability in the mouth, not its diagnostic accuracy.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
NexxZr™ are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Sagemax NexxZr™ T and NexxZr™ S are zirconium dioxide-yttrium oxide ceramic material - pressed into pre-sintered discs intended for further processing using computer aided manufacturing by a dental laboratory or other similar establishment, under the order of a physician/dentist. The dentist prepares the surface(s) of the natural teeth, then cements (lutes) the restoration in place with standard dental adhesives materials. Sagemax NexxZr™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers. The material is radioopaque, for ready visualization.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
anterior and posterior segment
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental laboratory or other similar establishment, under the order of a physician/dentist
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)
Measurements of the physical characteristics showed that the material has the same mechanical (flexural strength) and chemical stability (solubility) as our predicate device.
The physio-chemical properties of the raw material used in Sagemax devices, in addition to its technological characteristics are the same as in our previously cleared predicate device. The substantial equivalence of the intended use has also been proven by material testing (flexural strength - ISO 6872: 2008) and clinical performance.
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
SECTION 4: 510(k) SUMMARY
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Submitter Information: SAGEMAX BIOCERMAICS, INC., 34210 9th Avenue I. South, Suite 118, Federal Way, WA 98003 USA Contact Person: Katie J. Kosty -Phone: 877-386-0389, Fax: 888-856-2615
Date Prepared: November 26, 2013 -
Classification: Porcelain powder for clinical use, EIH, Class II, described in CFR II. 872.6660.
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Common/Usual Name: Dental restorative material, porcelain powder/blocks III.
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Proprietary Names: NexxZr™ S and NexxZr"™ T (formerly Sagemax Z-Blank™) IV.
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Establishment Registration Number: 3007518500 V.
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Indications for Use: NexxZr™ are intended for the fabrication and preparation of VI. copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
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Device Description: Sagemax NexxZr™ T and NexxZr™ S are zirconium dioxide-VII. yttrium oxide ceramic material - pressed into pre-sintered discs intended for further processing using computer aided manufacturing by a dental laboratory or other similar establishment, under the order of a physician/dentist. The dentist prepares the surface(s) of the natural teeth, then cements (lutes) the restoration in place with standard dental adhesives materials. Sagemax NexxZr™ prostheses are alternatives to gold, amalgam, ceramic, porcelain, or composite filling materials, more closely resembling gold inlays or porcelain inlays, onlays or veneers. The material is radioopaque, for ready visualization.
NexxZr™ products are a modification of the previous version, Sagemax Z-Blank™
- Substantial Equivalence: Sagemax NexxZx™ materials are substantially equivalent VIII. to our current, legally marketed device, K062695, Sagemax Z-Blanks; they are intended for the same purpose, namely to fabricate crowns (temporary or permanent) that are fully anatomical and contoured mimicking natural teeth. Yttrium-stabilized zirconia has been studied extensively for use in medical applications. The material is inert (biocompatible) and ideal for long-term implantable devices that resist failure under extreme load and stress. There are numerous dental devices that have been cleared by the Agency that apply the same fundamental scientific technology with regard to design and process. These devices have shown to be substantially equivalent in safety and/or effectiveness to the predicate device. Therefore, NexxZr™ S and NexxZr™ T are substantially equivalent to the following predicate device:
K062695 - Sagemax Bioceramics - Sagemax Z-Blank
1
Description of Safety and Substantial Equivalence:
Technological Characteristics
NexxZr" is an oxide-based ceramic composed of isostatically pressed, partially sintered, yttria-stabilized zirconia powder. NexxZr 10 is tested according to ISO 6872: 2008 Type II/Class 6 to ensure intended strength. This material is similar to dental alloys containing gold. Predicate devices have been used extensively and were found to be safe for dental use. The devise has the same technological characteristics and composition as the predicate device Sagemax Z-blank™.
Non-Clinical Performance Data
Measurements of the physical characteristics showed that the material has the same mechanical (flexural strength) and chemical stability (solubility) as our predicate device.
Conclusion as to Substantial Equivalence
The physio-chemical properties of the raw material used in Sagemax devices, in addition to its technological characteristics are the same as in our previously cleared predicate device. The substantial equivalence of the intended use has also been proven by material testing (flexural strength - ISO 6872: 2008) and clinical performance.
The devices are meant to be used in the same manner as current, legally marked devices. They are intended to be used in conjunction with CAD/CAM systems that meet the requirements under the recently issued FDA Class II Special Controls Guidance for Optical Impression Systems.
2
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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 10, 2014
Sagemax Bioceramics, Inc. Ms. Kathryn J. Kosty Vice President 34210 9th Avenue South, Suite 118 Federal Way, WA 98003
Re: K130991
Trade/Device Name: NexxZr® T and NexxZr® S Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: II Product Code: EIH Dated: December 2, 2013 Received: December 5, 2013
Dear Ms. Kosty:
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 - Ms. Kosty
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 801); medical device reporting (reporting of medical device-related 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/Industry/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/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 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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Image /page/3/Figure/6 description: The image shows the name "Kwame Oduimer -S" in a stylized font. The name is written in black ink on a white background. The letters are bold and have a slightly distressed appearance. The letters "Oduimer" are stylized with geometric shapes.
for
Erin I. Keith, 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
4
Indications for Use
510{k) Number (if known) K130991
Device Name NexxZx S and NexxZr T
Indications for Use (Describe)
Indications for Use (2837109)
NexxZr T and NexxZr S are intended for the fabrication and preparation of copings and full anatomical/full contour crowns, bridges, inlays, and onlays for anterior and posterior segment restorations.
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) (Signalure)
PSC Publishing Services (101) 443-4740
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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