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.

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.

NexxZr™ products are a modification of the previous version, Sagemax Z-Blank™

AI/ML Overview

The provided text describes a 510(k) summary for the dental prosthetic materials NexxZr™ S and NexxZr™ T, which are zirconium dioxide-yttrium oxide ceramic materials. The submission seeks substantial equivalence to a predicate device, Sagemax Z-Blank™ (K062695).

However, the document does not contain information about:

Specific quantitative acceptance criteria for the device's performance.
A detailed study proving the device meets acceptance criteria, including sample sizes, data provenance, ground truth establishment, or expert involvement.
Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.

The document primarily focuses on establishing substantial equivalence based on material composition and physical characteristics, asserting that the new devices have the same technological characteristics and similar mechanical and chemical stability as the predicate device.

Based on the provided text, I cannot complete a table of acceptance criteria and reported device performance or provide the detailed study information requested. The document states:

"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."
"Measurements of the physical characteristics showed that the material has the same mechanical (flexural strength) and chemical stability (solubility) as our predicate device."
"The substantial equivalence of the intended use has also been proven by material testing (flexural strength - ISO 6872: 2008) and clinical performance."

This indicates that the material was tested, but the results of these tests, specific acceptance criteria values, sample sizes, and detailed methodology are not included in this 510(k) summary.

Therefore, I can only provide what is explicitly stated or can be inferred:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Not Explicitly Stated as Quantitative Criteria)	Reported Device Performance (Summary Statements)
Material Composition	Oxide-based ceramic composed of isostatically pressed, partially sintered, yttria-stabilized zirconia powder. (Same as predicate)
Technological Characteristics	Same as predicate device Sagemax Z-blank™.
Mechanical Strength (e.g., Flexural Strength)	Tested according to ISO 6872:2008 Type II/Class 6 to ensure intended strength. Material has the "same mechanical (flexural strength)" as the predicate device. (Specific values not provided in this summary).
Chemical Stability (e.g., Solubility)	Material has the "same... chemical stability (solubility)" as the predicate device. (Specific values not provided in this summary).

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Sample Size: Not specified in the provided text. The text only mentions "Measurements of the physical characteristics showed..." and "material testing (flexural strength - ISO 6872: 2008)".
Data Provenance: Not specified.
Retrospective/Prospective: Not specified, but generally, material characterization tests as described are prospective laboratory tests rather than clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The "ground truth" here refers to the material's physical and chemical properties, measured objectively through standardized tests (e.g., ISO 6872:2008). No human expert consensus was needed to establish these empirical ground truths.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. This concept typically applies to clinical studies where human interpretation or classification is involved. Material testing involves objective measurements, not adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a dental material, not an AI or imaging diagnostic or assistive device for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for proving substantial equivalence was based on objective material property measurements (e.g., flexural strength, solubility) performed according to international standards (ISO 6872:2008) and comparison to the predicate device's properties.

8. The sample size for the training set

Not applicable. This device is a material, not a machine learning model. There is no concept of a "training set" in this context.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set for this type of device.

Summary

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SECTION 4: 510(k) SUMMARY

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.
Common/Usual Name: Dental restorative material, porcelain powder/blocks III.
Proprietary Names: NexxZr™ S and NexxZr"™ T (formerly Sagemax Z-Blank™) IV.
Establishment Registration Number: 3007518500 V.
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.
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

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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.

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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

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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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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:

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Regulation Number and Section

§ 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.