HCG Zirconia Ceramic Block

K193090 · Hocheng Corporation · EIH · Oct 29, 2020 · Dental

Device Facts

• Record ID: K193090
• Device Name: HCG Zirconia Ceramic Block
• Applicant: Hocheng Corporation
• Product Code: EIH · Dental
• Decision Date: Oct 29, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

HCG Zirconia Ceramic Block 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 Story

HCG Zirconia Ceramic Block is a ceramic material composed of zirconia compounds (ZrO2, Y2O3, Al2O3). It serves as a raw material for dental laboratories or clinics to fabricate dental restorations. The blocks are processed via conventional manual milling or CAD/CAM systems to create copings, crowns, bridges, inlays, and onlays. The device is non-sterile and intended for use by dental professionals. The final restoration is placed in the patient's mouth to restore dental function and aesthetics. The device provides a durable, biocompatible ceramic structure for long-term dental rehabilitation.

Clinical Evidence

No clinical data was used to support the substantial equivalence determination. Evidence is based on non-clinical bench testing, including biocompatibility (ISO 10993-5, -4, -11, -10, -6, USP <151>), shelf life (ASTM F1980), and functional testing (ISO 6872, ISO 13356, CNS 13983, CNS 13958).

Technological Characteristics

Ceramic block composed of ZrO2, Y2O3, and Al2O3. Form factor: round disks and square blocks. Flexural strength > 800 MPa. Non-sterile. Complies with ISO 6872, ISO 13356, and biocompatibility standards (ISO 10993 series).

Indications for Use

Indicated for patients requiring dental restorations including copings, full anatomical/full contour crowns, bridges, inlays, and onlays in anterior and posterior segments.

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

• NexxZr™ S and NexxZr™ T (K130991)

Reference Devices

• Copran Zr/Origin YZ (K092496)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which 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.

October 29, 2020

Hocheng Corporation Chieh-Ju Huang Manager 1F.,No.398, Xingshan Rd., Neihu Dist. Taipei City, 11469 TAIWAN

Re: K193090

Trade/Device Name: HCG Zirconia Ceramic Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: July 29, 2020 Received: July 31, 2020

# Dear Chieh-Ju Huang:

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 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

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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 "Nandu" Nandkumar, Ph.D. 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) K193090

Device Name HCG Zirconia Ceramic Block

Indications for Use (Describe)

HCG Zirconia Ceramic Block are intended for the fabrication 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) | |
|-------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| <div> <span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> <span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# 510(k) SUMMARY

- Traditional 1. Type of Submission:
- 10/26/2020 Date of Summary: 2.
- HOCHENG CORPORATION 3. Submitter: 1F.,No.398, Xingshan Rd., Neihu Dist., Taipei City Address: 11469, Taiwan (R.O.C.) Phone: [phone] Fax: [phone] Representative: CHIU-LI-CHIEN ([e-mail])

#### 4. Identification of the Device:

| Proprietary/Trade name: | HCG Zirconia Ceramic Block |
|------------------------------|------------------------------------|
| Classification Product Code: | EIH |
| Regulation Number: | 872.6660 |
| Regulation Description: | Porcelain powder for clinical use. |
| Review Panel: | Dental |
| Device Class: | II |

#### 5. Identification of the Predicate Device:

| Predicate Device Name: | NexxZr™ S and NexxZr™ T |
|------------------------------|---------------------------|
| Manufacturer: | Sagemax Bioceramics, Inc. |
| Classification Product Code: | EIH |
| Regulation number: | 872.6660 |
| Device Class: | II |
| 510(k) Number: | K130991 |

#### 6. Identification of the Reference Device:

| Reference Device Name: | Copran Zr/Origin YZ |
|------------------------|----------------------------------|
| Manufacturer: | White Peaks Dental System GmbH & |

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| | Company KG |
|------------------------------|------------|
| Classification Product Code: | EIH |
| Regulation number: | 872.6660 |
| Device Class: | II |
| 510(k) Number: | K092496 |

#### 7. Indications for Use / Intended Use of the Device

HCG Zirconia Ceramic Block 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.

#### Description of the Device 8.

"HCG Zirconia Ceramic Block" is a ceramic block composed of zirconia compounds. It is suitable for manufacture of dental crowns and bridges cut in the conventional manner or with the help of CAD/CAM.

#### 9. Non-clinical Testing

A series of tests were conducted on the subject device, HCG Zirconia Ceramic Block.

| Scope | Reference | Acceptance Criteria by Test Item | Test Result and SE |
|------------------|-------------|-------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Shelf life | ASTM F1980 | Visual inspection, Flexural<br>strength, Chemical extraction, and<br>Coefficient of linear expansion. | After aging, the test results<br>met the pre-defined criteria<br>according to the test standards.<br>Thus the shelf life of the<br>device is verified to<br>demonstrate substantial<br>equivalence. |
| | ISO 6872 | | |
| Biocompatibility | ISO 10993-5 | In Vitro Cytotoxicity Test, | All the test results met the<br>pre-defined criteria according<br>to the test standards. Thus the |
| | ISO 10993-4 | Hemolysis Test, Acute Systemic<br>Toxicity Study, Skin Sensitization | |

K193090

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### HOCHENG CORPORATION HCG Zirconia Ceramic Block

### K193090

| | ISO 10993-11 | Study, White Rabbit<br>Intracutaneous Reactivity Test, | biocompatibility of the device<br>is verified to demonstrate<br>substantial equivalence. |
|-----------------------|--------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | ISO 10993-10 | White Rabbit Pyrogen Test, | |
| | USP <151> | Muscle Implant Study, and<br>Repeated Dose 90-Day | |
| | ISO 10993-6 | Subchronic Oral Toxicity Study in<br>Rat | |
| Functional<br>testing | ISO 6872 | Production quality of zirconia<br>ceramic block, Size measurement<br>of supporting shaft, and Efficacy | All the test results met the<br>pre-defined criteria according<br>to the test standards, so the |
| | ISO 13356 | of the subject, predicate and<br>reference devices (basic physical<br>and chemical characteristics) | efficacy of the subject device<br>is verified. The comparative<br>testing of efficacy is also |
| | CNS 13983 | | conducted on all devices, and |
| | CNS 13958 | | the test results demonstrate<br>substantial equivalence<br>between subject, predicate and<br>reference devices. |

# 10. Clinical and Usability Testing

No clinical test data was used to support the decision of substantial equivalence.

# 11. Substantial Equivalence Determination

| Equivalence, same and difference between the devices are cited as below. |
|--------------------------------------------------------------------------|
| |

| Item | Subject device | Predicate device | Reference device | Substantial<br>Equivalence<br>Discussion |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | HCG Zirconia<br>Ceramic Block | NexxZr™ S and<br>NexxZr™ T | Copran Zr/Origin YZ | |
| 510(k) No. | K193090 | K130991 | K092496 | |
| Indication<br>For Use / | HCG Zirconia<br>Ceramic Block are | NexxZr™ are<br>intended for the | Copran Zr/ Origin YZ<br>Zirconia blanks are | Equivalent<br>All the devices are |
| Intended Use | intended for the<br>fabrication and<br>preparation of<br>copings and full<br>anatomical/full<br>contour crowns,<br>bridges, inlays, and<br>onlays for anterior<br>and posterior<br>segment restorations. | fabrication and<br>preparation of<br>copings and full<br>anatomical/full<br>contour crowns,<br>bridges, inlays, and<br>onlays for anterior<br>and posterior<br>segment restorations. | presintered blanks for CAD<br>of CAM or manual milling,<br>made from biocompatible,<br>tetragonal and<br>polycrystalline<br>zirconiumdioxyde.<br>Milling blanks designed<br>for:<br>- Crown frameworks in<br>the anterior and<br>posterior areas<br>- Bridge frameworks in<br>the anterior and<br>posterior areas<br>- Primary conical crowns<br>and telescopic crowns<br>- Cantilevered bridges<br>with a max. of one<br>pontic having a<br>premolar width<br>- Inlays, Onlays, Veneers | zirconia blocks and used<br>for preparation of dental<br>crowns, bridges, inlays,<br>and onlays. Although<br>the reference device has<br>more specific usages on<br>the crowns, bridges and<br>veneers, the usage scope<br>of subject device is<br>smaller than that of<br>reference device and the<br>same as that of predicate<br>device. Thus the<br>differences between<br>subject and reference<br>devices does not raise<br>new issues of SE. |
| Shape | round blocks (disks)<br>and square blocks | disks | may be disks, cubes, bars,<br>and cylinders. | Equivalent<br>Both subject device and<br>reference device have<br>the same shape. |
| Main<br>component | ZrO2; Y2O3; Al2O3 | ZrO2; Y2O3; HfO2;<br>Al2O3 | (undisclosed) | Different but meet the<br>requirement and does<br>not raise new issues of<br>SE. |
| Model | 8 colors<br>(Ultra transparently<br>white, Transparently | multi colors<br>(White, 16 A-D<br>shades, and 3 Bleach | multi colors<br>(White, and multiple shades<br>for Light, Medium and | Equivalent<br>All the devices have<br>multi colors of white |
| | white, Light,<br>Intermediate, Dark,<br>Ultra-high<br>transparently white,<br>Light gradient, Dark<br>gradient) | shades) | Intense) | and customized shades.<br>The subject device is<br>met the requirement and<br>the difference of shades<br>does not raise new<br>issues of SE. |
| Flexural<br>Strength | > 800 MPa | > 800 MPa | > 800 MPa | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Main<br>compliance | ISO 6872 | ISO 6872 | (undisclosed) | Same |

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## HOCHENG CORPORATION HCG Zirconia Ceramic Block

# K193090

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### K193090

### HOCHENG CORPORATION HCG Zirconia Ceramic Block

# 12. Similarity and Difference

The HCG Zirconia Ceramic Block is compared with NexxZr™ S and NexxZr™ T and Copran Zr/Origin YZ. The subject device has same intended use and technology/mechanism of action, and similar safety and performance as the predicate and reference devices. Although there are some different specifications between these devices, the performance test was completed and demonstrated similar test results. The subject device has also undergone safety and performance tests, and the results complied with the test requests. Therefore, the differences between the subject device and the predicate and reference devices do not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate and reference devices in intended use, design and performance claims.

## 13. Conclusion

After analyzing non-clinical laboratory studies and testing data, it can be concluded that the HCG Zirconia Ceramic Block is substantially equivalent to the predicate and reference devices.