Zmaxx T Series

K161219 · Maxx Digm, Inc. · EIH · Jan 26, 2017 · Dental

Device Facts

• Record ID: K161219
• Device Name: Zmaxx T Series
• Applicant: Maxx Digm, Inc.
• Product Code: EIH · Dental
• Decision Date: Jan 26, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Zmaxx T Series is used in the manufacture of dental prosthetics.

Device Story

Zmaxx T Series is a zirconia-based ceramic material provided in various shapes (round, square) and sizes; used to manufacture cores of all-ceramic crowns. Input consists of physical ceramic blocks; processed via CAD/CAM milling machines using digital design files. Output is a custom-milled dental prosthetic core. Used in dental laboratories; operated by dental technicians. Healthcare providers use the final prosthetic to restore patient tooth structure and function. Benefits include patient-specific tooth color matching and structural restoration.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 6872 (flexural strength, thermal expansion, chemical solubility, density, shrinkage) and ISO 13356 (monoclinic phase rate). Biocompatibility testing performed per ISO 10993-5 (cytotoxicity), ISO 10993-10 (sensitization and irritation), and ISO 10993-11 (acute systemic toxicity). Results support substantial equivalence.

Technological Characteristics

Zirconia-based ceramic (ZrO2, HfO2, Y2O3, Al2O3, SiO2, Fe2O3, Er2O3). Classified as ISO 6872 Type 2 Class 4. Form factor: various shapes/sizes for CAD/CAM jigs. Processing: CAD/CAM milling. Biocompatibility: ISO 10993 compliant.

Indications for Use

Indicated for use in the manufacture of dental prosthetics; no specific patient population, age, or gender restrictions provided.

Regulatory Classification

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.

Predicate Devices

• NATURAZ SERIES (K091096)
• BruxZir™ Anterior (K143330)

Submission Summary (Full Text)

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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 the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|-----------------------------------------------------------------------------------------------|---------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | 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: [phone] Fax: [phone]

#### 2. Submission Correspondent:

Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Fax: [phone] Phone: [phone] Email: [e-mail]

#### 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 for<br>clinical use | Porcelain, Powder for clinical<br>use | Porcelain, Powder for clinical<br>use |
| 510k Applicant | Maxx Digm, Inc. | The Dental Solutions, Inc. | Prismatik Dentalcraft, Inc. |
| Contract<br>Manufacturer | DMAX Co. Ltd. | DMAX Co., Ltd. | |
| Indication For Use | Zmaxx T Series is used in<br>the manufacture of dental<br>prosthetics. DMAX CO.,<br>LTD proposes that the<br>materials distributed within<br>the United States be labeled | NaturaZ Series is used in the<br>manufacture of dental<br>prosthetics. The Dental<br>Solution, Inc. proposes that<br>the materials distributed<br>within the United States be<br>labeled:<br>"Caution: Federal (US) law<br>restricts the sale of the device<br>to, or on the order of, licensed<br>professionals." | The device is indicated for use<br>by dental technicians in the<br>construction of custom<br>made all ceramic restorations<br>for anterior and posterior<br>location. |
| CTE(coefficient of<br>thermal expansion | $(10.6±0.5)×10^{-6}K^{-1}$<br>(meeting the ISO 6872<br>requirement) | $(11.5±0.5)×10^{-6}K^{-1}$<br>(meeting the ISO 6872<br>requirement) | $11 ×10^{-6}K^{-1}$<br>(meeting the ISO 6872<br>requirement) |
| Flexural strength | >600MPa<br>(meeting the ISO 6872<br>requirement) | >800MPa<br>(meeting the ISO 6872<br>requirement) | >650MPa<br>(meeting the ISO 6872<br>requirement) |
| Chemical solubility | $<2000 µg/cm²$<br>(meeting the ISO 6872<br>requirement) | $<100 µg/cm²$<br>(meeting the ISO 6872<br>requirement) | $<2000 µg/cm²$<br>(meeting the ISO 6872<br>requirement) |
| Material Component | ZrO2, HfO2, Y2O3, Al2O3,<br>SiO2, Fe2O3, Er2O3 | ZrO2, HfO2, Y2O3, Al2O3, SiO2<br>Fe2O3 | ZrO2, HfO2, Y2O3, Al2O3, SiO2<br>Fe2O3, Er2O3 |
| Shade | A0, A0.5, A2 | A0 | 5 shades |
| Principle of<br>Operation | Install the block on milling<br>machine, upload a designed<br>file and process it | Install the block on milling<br>machine, upload a designed<br>file and process it | Install the block on milling<br>machine, upload a designed file<br>and process it |

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| Biocompatibility | Non-toxic and biocompatible<br>(Meeting the ISO 10993-5,<br>10 and<br>10993-11 requirements) | Non-toxic and biocompatible<br>(Meeting the ISO 10993-5, 10<br>and<br>10993-11 requirements) | Non-toxic and biocompatible<br>(Meeting the ISO 10993-3, 5,1<br>and10993-11 requirements) |
|------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|
|------------------|----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|

#### 9. Conclusion:

Based on the testing results, Maxx Digm, Inc. concludes that the Zmaxx T Series are substantially equivalent to the predicate device.