(272 days)
Zmaxx T Series is used in the manufacture of dental prosthetics.
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
This document describes the Zmaxx T Series, a zirconia-based ceramic used in the manufacture of dental prosthetics. The submission is a 510(k) summary, aiming to establish substantial equivalence to existing predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Zmaxx T Series are based on conformity to international standards, primarily ISO 6872 for dental ceramics, and ISO 10993 for biocompatibility.
| Acceptance Criteria (Standard) | Reported Device Performance (Zmaxx T Series) | Predicate Device 1 (NATURAZ SERIES) Performance | Predicate Device 2 (BruxZir™ Anterior) Performance |
|---|---|---|---|
| ISO 6872 Requirements: | |||
| COE (Coefficient of Thermal Expansion) | $(10.6 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $(11.5 \pm 0.5) \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) | $11 \times 10^{-6} K^{-1}$ (meeting the ISO 6872 requirement) |
| Flexural Strength | >600 MPa (meeting the ISO 6872 requirement) | >800 MPa (meeting the ISO 6872 requirement) | >650 MPa (meeting the ISO 6872 requirement) |
| Chemical Solubility | <2000 µg/cm² (meeting the ISO 6872 requirement) | <100 µg/cm² (meeting the ISO 6872 requirement) | <2000 µg/cm² (meeting the ISO 6872 requirement) |
| Freedom of Extraneous Materials, Radiation Emission, Density, Shrinkage Factor | Tested as per ISO 6872; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary, but implied to meet requirements as a predicate. | Not explicitly stated in the summary, but implied to meet requirements as a predicate. |
| ISO 10993 Requirements (Biocompatibility): | |||
| Cytotoxicity (ISO 10993-5) | Non-toxic and biocompatible (Meeting the ISO 10993-5 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-5 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 1 and 10993-11 requirements) - Note: ISO 10993-3 and 10993-1 mentioned for Predicate 2, but not for Subject or Predicate 1 for Cytotoxicity |
| Sensitization & Irritation (ISO 10993-10) | Non-toxic and biocompatible (Meeting the ISO 10993-10 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-10 requirement) | Not explicitly listed as 10993-10, but covered under "Non-toxic and biocompatible" with other ISOs. |
| Acute Systemic Toxicity (ISO 10993-11) | Non-toxic and biocompatible (Meeting the ISO 10993-11 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-11 requirement) | Non-toxic and biocompatible (Meeting the ISO 10993-3, 5, 1 and 10993-11 requirements) |
| Other Bench Testing: | |||
| Visual Inspection, Dimension Accuracy, Package, Uniformity | Tested; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary. | Not explicitly stated in the summary. |
| ISO 13356 Mono Clinic Phrase Rate | Tested; results "support substantial equivalence" (specific values not provided in this summary) | Not explicitly stated in the summary. | Not explicitly stated in the summary. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the exact sample sizes (number of units or specimens) used for each of the non-clinical tests (e.g., flexural strength, chemical solubility, biocompatibility). It only states that "All the test results support substantial equivalence to the predicate devices."
The data provenance is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that the testing was conducted by the manufacturer, Maxx Digm, Inc., or its contract manufacturer (DMAX Co., Ltd.) to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This document describes a non-clinical performance and biocompatibility study for a dental material (zirconia-based ceramic). It does not involve human subjects, image analysis, or diagnostic tasks that would typically require independent expert review or "ground truth" establishment in the way described (e.g., radiologists interpreting images). The "ground truth" for this device's performance is established by the specified ISO standards and the quantitative measurement methods outlined within those standards.
4. Adjudication Method for the Test Set
Not applicable. The study is a non-clinical laboratory evaluation against specified ISO standards and does not involve subjective interpretations or the need for adjudication among multiple reviewers.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is a non-clinical evaluation of a medical device material against established performance standards and predicate devices. MRMC studies are typically used for diagnostic devices that involve human interpretation of clinical data (e.g., images).
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, in essence. The performance testing described is "standalone" in that it assesses the physical, chemical, and biological properties of the material itself, independent of human interaction in its final clinical application (beyond the standardized testing procedures). This is not an algorithm, but rather a material's intrinsic properties.
7. The Type of Ground Truth Used
The ground truth for this study is based on established international standards (ISO 6872, ISO 10993-5, ISO 10993-10, ISO 10993-11). These standards define the acceptable ranges and methodologies for evaluating dental ceramic materials for properties such as flexural strength, thermal expansion, chemical solubility, and biocompatibility.
8. The Sample Size for the Training Set
Not applicable. This is a non-clinical performance study of a material and does not involve machine learning algorithms that require a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set involved, the concept of establishing ground truth for it does not apply.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Maxx Digm, Inc. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K161219
Trade/Device Name: Zmaxx T Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 28, 2016 Received: April 29, 2016
Dear Priscilla Chung:
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 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
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Page 2 - Priscilla Chung
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 vours.
Susan Russo, DDS, MA
Tina Kiang, Ph.D. 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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Indications for Use
510(k) Number (if known)
Device Name
Zmaxx T Series
Indications for Use (Describe)
Zmaxx T Series is used in the manufacture of dental prosthetics.
| 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) |
| | Prescription Use (Part 21 CFR 801 Subpart D)
|__| Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
(K161219)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: _ December 27, 2016
Applicant / Submitter: 1.
Maxx Digm, Inc.
3265 Kifer Road Santa Clara, CA 95051
Tel: 408-462-9608 Fax: 408-542-9871
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Zmaxx T Series |
|---|---|
| Common Name: | Dental Frame Material for Dental Prosthesis |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
4. Predicate Device:
Primary Predicate Device: NATURAZ SERIES (K091096) by The Dental Solutions, Inc. Reference Predicate Device: BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc.
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5. Device Description:
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
Zmaxx T Series offers various types as follows: W-type, T-type, Z-type, A-type, C-type, B-type, K-type, and Q-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. User can choose a type which fits the jig they have.
| Type | Size Range | Weight Range |
|---|---|---|
| W-type | 98.5mm(D) x 10-25mm(T) | 250-580g |
| T-type | 100mm(D) x 10-25mm(T) | 250-615g |
| D-type | 98mm(D) x 10-25mm(T) | 250-595g |
| Z-type | 95mm(D) x 10-30mm(T) | 230-700g |
| A-type | 90mm(W)×73mm(L)×12-25mm(H) | 210-420g |
| C-type | 15.5-22mm(W)×19-25(L)×20-65(H) | 20-125g |
| B-type | 65(W)×35(L)×12-22mm(H) | 85-155g |
| K-type | 75(W)×45(L)×12-22mm(H) | 127-260g |
| Q-type | 100(W)×100(L)×12-22mm(H) | 380-665g |
6. Indications for Use:
Zmaxx T Series is used in the manufacture of dental prosthetics.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- · ISO 6872 Freedom of Extraneous Materials , Radiation Emission , Flexural Strength,
- · Thermal Expansion Coefficient, Chemical Solubility, Density, Shrinkage Factor
- · ISO 13356 Mono Clinic Phrase Rate
- · ISO 10993-5 Cytotoxicity
- · ISO 10993-10 Sensitization & Irritation
- · ISO 10993-11 Acute Systemic Toxicity
- · Other bench testing Visual Inspection, Dimension Accuracy, Package, Uniformity
8. Substantial Equivalence
The Zmaxx T Series is substantially equivalent to the NATURAZ SERIES (K091096) by The Dental Solutions, Inc. and BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. The following comparison table is presented to demonstrate substantial equivalence. They share the similar
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material and similar physical / chemical properties. However, the mixing ratios of the raw materials are different between the devices.
Despite these differences, the performance test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate devices in physical and chemical properties and meets the necessary requirements. In addition, the subject device has been tested for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11) to meet the biocompatibility requirements.
Based on the comparison between the two devices and the performance testing results presented in this 510K, we conclude that the Zmaxx T Series is substantially equivalent to the predicate devices.
| Subject Device | Primary Predicate Device | Reference Predicate Deice | |
|---|---|---|---|
| 510(k) Number | K161219 | K091096 | K143330 |
| Device Name | Zmaxx T Series | NATURAZ SERIES | BruxZir™ Anterior |
| Common Name | Porcelain, Powder forclinical use | Porcelain, Powder for clinicaluse | Porcelain, Powder for clinicaluse |
| 510k Applicant | Maxx Digm, Inc. | The Dental Solutions, Inc. | Prismatik Dentalcraft, Inc. |
| ContractManufacturer | DMAX Co. Ltd. | DMAX Co., Ltd. | |
| Indication For Use | Zmaxx T Series is used inthe manufacture of dentalprosthetics. DMAX CO.,LTD proposes that thematerials distributed withinthe United States be labeled | NaturaZ Series is used in themanufacture of dentalprosthetics. The DentalSolution, Inc. proposes thatthe materials distributedwithin the United States belabeled:"Caution: Federal (US) lawrestricts the sale of the deviceto, or on the order of, licensedprofessionals." | The device is indicated for useby dental technicians in theconstruction of custommade all ceramic restorationsfor anterior and posteriorlocation. |
| CTE(coefficient ofthermal expansion | $(10.6±0.5)×10^{-6}K^{-1}$(meeting the ISO 6872requirement) | $(11.5±0.5)×10^{-6}K^{-1}$(meeting the ISO 6872requirement) | $11 ×10^{-6}K^{-1}$(meeting the ISO 6872requirement) |
| Flexural strength | >600MPa(meeting the ISO 6872requirement) | >800MPa(meeting the ISO 6872requirement) | >650MPa(meeting the ISO 6872requirement) |
| Chemical solubility | $<2000 µg/cm²$(meeting the ISO 6872requirement) | $<100 µg/cm²$(meeting the ISO 6872requirement) | $<2000 µg/cm²$(meeting the ISO 6872requirement) |
| Material Component | ZrO2, HfO2, Y2O3, Al2O3,SiO2, Fe2O3, Er2O3 | ZrO2, HfO2, Y2O3, Al2O3, SiO2Fe2O3 | ZrO2, HfO2, Y2O3, Al2O3, SiO2Fe2O3, Er2O3 |
| Shade | A0, A0.5, A2 | A0 | 5 shades |
| Principle ofOperation | Install the block on millingmachine, upload a designedfile and process it | Install the block on millingmachine, upload a designedfile and process it | Install the block on millingmachine, upload a designed fileand process it |
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| Biocompatibility | Non-toxic and biocompatible(Meeting the ISO 10993-5,10 and10993-11 requirements) | Non-toxic and biocompatible(Meeting the ISO 10993-5, 10and10993-11 requirements) | Non-toxic and biocompatible(Meeting the ISO 10993-3, 5,1and10993-11 requirements) |
|---|---|---|---|
| ------------------ | ---------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------- | ------------------------------------------------------------------------------------------- |
9. Conclusion:
Based on the testing results, Maxx Digm, Inc. concludes that the Zmaxx T Series are substantially equivalent to the predicate device.
§ 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.