ZMAXX Dental Zirconia Blanks

K191631 · Zmaxx Bioceramics, LLC · EIH · Nov 1, 2019 · Dental

Device Facts

• Record ID: K191631
• Device Name: ZMAXX Dental Zirconia Blanks
• Applicant: Zmaxx Bioceramics, LLC
• Product Code: EIH · Dental
• Decision Date: Nov 1, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Story

ZMAXX Dental Zirconia Blanks are zirconia-based ceramic blocks used by dental professionals for the fabrication of dental restorations; specifically artificial teeth, crowns, facings, and veneers. The device is supplied as a non-sterile blank in various heights, colors, and transparency levels. It is intended for milling into final dental prosthetics. The material is a tetragonal zirconia ceramic. The device is used in a dental laboratory or clinical setting; it is processed by dental technicians or clinicians using CAD/CAM milling equipment. The final restoration provides a durable, biocompatible replacement for natural tooth structure, benefiting patients requiring restorative dental care.

Clinical Evidence

No clinical data. Bench testing only. Performance verified per ISO 6872:2015 (Dentistry-Ceramic materials) and density testing. Biocompatibility verified per ISO 7405:2008 (cytotoxicity) and ISO 10993 series (intracutaneous reactivity, sensitization, acute systemic toxicity, genotoxicity).

Technological Characteristics

Material: Zirconia (ZrO2 >99.0%) with inorganic pigments (Al2O3, SiO2, Fe2O3, Er2O3). Form: Discs (12-25mm height). Crystal morphology: Tetragonal. Density: 6.00g/cm3. Sintering temperature: 1500±50°C. Classification: Type II Class 5 per ISO 6872:2015. Sterilization: Non-sterile. Connectivity: None (standalone material).

Indications for Use

Indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

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

• Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K160367)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 1, 2019

ZMAXX Bioceramics LLC % Ying Xu General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA

Re: K191631

Trade/Device Name: ZMAXX Dental Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 9, 2019 Received: August 23, 2019

Dear Ying Xu:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Srinivas Nandkumar, Ph.D. Acting Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known)

K191631

Device Name ZMAXX Dental Zirconia Blanks

Indications for Use (Describe)

ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--|
|-------------------------------------------------|--|

X Prescription Use (Part 21 CFR 801 Subpart D)

| | Over-The-Counter Use (21 CFR 801 Subpart C)

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# Tab #7 510(k) Summary

This 510(k) Summary is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _K191631

- 1. Date of Preparation: 05/10/2019
- Sponsor Identification 2.

## ZMAXX BIOCERAMICS LLC

231 PELICAN CT FOSTER CITY, CA 94404

Establishment Registration Number: Not yet registered for the Number

Contact Person: Josef Wu Position: General Manager Tel: [phone] Email: [e-mail]

- 3. Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)

Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China

Tel: [phone], Fax: [phone] Email: [e-mail]

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#### 4. Identification of Proposed Device

Trade Name: ZMAXX Dental Zirconia Blanks Common Name: Zirconia Blocks

#### Regulatory Information

Classification Name: Powder, Porcelain Classification: II Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental

Indication for Use:

ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Description

Dental Zirconia Blank is available in various specifications, which are combinations of height (12~25mm), color model (0M1/A1~ A3/B1~B4/C1~C4/D2~D4) and transparency model (T45).

- 5. Identification of Predicate Device
510(k) Number: K160367 Product Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Nissin-Metec China Co., Ltd

- 6. Non-Clinical Test Conclusion
Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device, including

- > Performance Test per ISO 6872: 2015, Dentistry-Ceramic materials
- > Density Test
- > Cytotoxicity per ISO 7405:2008;
- > Intracutaneous Reactivity Test per ISO 10993-10:2010;
- > Sensitization Test per ISO 10993-10:2010
- > Acute Systematic Toxicity per ISO 10993-11:2006;

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- ♪ Genotoxicity Tests per ISO 10993-3:2014.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| | | | Table 1 Comparison of Technology Characteristics |
|--|--|--|--------------------------------------------------|
|--|--|--|--------------------------------------------------|

| ITEM | Subject Device | Predicate Device K160367 |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Code | EIH | EIH |
| Regulation Number | 872.6660 | 872.6660 |
| Indication for Use | ZAMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. | Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. |
| Feature | Colored | Uncolored and Colored |
| Shape | discs | Semic, Rods, Blocks and Dics |
| Type and Class per ISO 6872 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-Sterile | Non-sterile |
| Chemical Composition<br>(Weight %) | ZrO2 >99.0%<br>Inorganic Pigment<br>(Al2O3, SiO2, Fe2O3, Er2O3) < 1% | ZrO2≥99.0%<br>Inorganic Pigment<br>(Fe2O3, Er2O3) ≤ 1% |
| Crystal Morphology | Tetragonal | Tetragonal |
| Density | 6.00g/cm3 | 6.00g/cm3 |
| Sintering<br>temperature | 1500±50°C | 1500±50°C |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 |
| Contact Level | surface device with permanent<br>contact (>30 days) | surface device with permanent<br>contact (>30 days) |
| Biocompatibility | Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react | Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react identified |

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| | | identified. | |
|--|--|-------------|--|
|--|--|-------------|--|

Subject device, Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank, is very similar to the predicate device, except for an additional Inorganic Pigment, the difference will not result in any new safety and effectiveness issue.

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- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.