Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

K180252 · Crown Porcelain Dental Technology Co., Ltd. · EIH · Apr 24, 2018 · Dental

Device Facts

• Record ID: K180252
• Device Name: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
• Applicant: Crown Porcelain Dental Technology Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Apr 24, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2

Intended Use

Crown Dental Zirconia Blank & Crown 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.

Device Story

Zirconia-based dental material supplied as discs; used by dental professionals to fabricate artificial teeth, crowns, facings, and veneers. Material undergoes sintering at 1500±50°C to achieve final form. Device serves as raw material for dental restorations; provides permanent contact (>30 days) with oral tissues. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

No clinical data. Bench testing only, including performance testing per ISO 6872:2015, density testing, and biocompatibility testing (cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, and genotoxicity) per ISO 10993 standards.

Technological Characteristics

Zirconia (ZrO2 >99.0%) ceramic material with inorganic pigments (Al2O3, SiO2, Fe2O3, Er2O3 <1%). Tetragonal crystal morphology. Density 6.00g/cm³. Sintering temperature 1500±50°C. Complies with ISO 6872 (Type II Class 5). Non-sterile. Form factor: discs.

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 logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in a larger, bolder font, and "ADMINISTRATION" in a smaller font below.

Crown Porcelain Dental Technology Co., Ltd. % Diana Hong General Manager Mid-Link Consulting Co.,Ltd. P.O. Box 120-119 Shanghai, 200120 Cn

April 24, 2018

## Re: K180252

Trade/Device Name: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: February 27, 2018 Received: March 7, 2018

## Dear Diana Hong:

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 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);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Mary S. Runner -S

for 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) K180252

Device Name

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank

Indications for Use (Describe)

Crown Dental Zirconia Blank & Crown 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.

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: ____

- 1. Date of Preparation: 02/24/2018
- 2. Sponsor Identification

## Crown Porcelain Dental Technology Co., Ltd. 5F.-1, No.189, Sec.2, Keelung Rd., Xinyi Dist.,

Taipei City 110, Taiwan

Establishment Registration Number: Not yet registered for the Number

Contact Person: Chu Lien Fan Position: General Manager Tel: [phone] ext.11 Fax: [phone] Email: [e-mail]

#### 3. Designated Submission Correspondent

Ms. Diana Hong (Primary Contact Person) Ms. Betty Xiao (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: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank Common Name: Zirconia Blocks

#### Regulatory Information

Classification Name: Powder, Porcelain Classification: 2 Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental

Intended Use Statement:

Crown Dental Zirconia Blank & Crown 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.

Device Description

Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank are available in discs shape, and in various specifications, which are combinations of height (10~25mm), color model (0M1/A1~A4/B1~B4/C1~C4/D2~D4) and transparency model (T41/T45/T49/TR).

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

- Non-Clinical Test Conclusion 6.
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 Fourth Edition 2015-06-01, Dentistry - Ceramic Materials.
- > Density Test
- > Cytotoxicity per ISO 10993-5:2009;
- > Intracutaneous Reactivity Test per ISO 10993-10:2010;
- A Sensitization Test per ISO 10993-10:2010

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- > Acute Systematic Toxicity per ISO 10993-11:2006;
- > Genotoxicity Tests per ISO 10993-3:2014.
- 7. Clinical Test Conclusion

No clinical study is included in this submission.

- Substantially Equivalent (SE) Comparison 8.

| ITEM | Subject Device | Predicate Device |
|-----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Crown Dental Zirconia Blank &<br>Crown Dental Zirconia Pre-Shaded<br>Blank | K160367 |
| Product Code | EIH | EIH |
| Regulation<br>Number | 872.6660 | 872.6660 |
| Intended Use | Crown Dental Zirconia Blank &<br>Crown Dental Zirconia Pre-Shaded<br>Blank are indicated for the production<br>of artificial teeth in fixed or<br>removable dentures, or for jacket<br>crowns, facings, and veneers. | Nissin Dental Zirconia Blank &<br>Dental Zirconia Pre-Shaded Blank<br>are indicated for the production of<br>artificial teeth in fixed or removable<br>dentures, or for jacket crowns,<br>facings, and veneers |
| Feature | Colored | Uncolored and Colored |
| Shape | Discs | Semic, Rods, Blocks and Discs |
| Type and Class<br>per ISO 6872:<br>2015 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-sterile | Non-Sterile |
| Chemical | ZrO2>99.0% | ZrO2≥99.0% |
| Composition<br>(Weight %) | Inorganic Pigment<br>(Al2O3, SiO2, Fe2O3, Er2O3) < 1% | Inorganic Pigment<br>(Fe2O3, Er2O3) ≤ 1% |
| Crystal<br>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 contact<br>(>30 days) | surface device with permanent<br>contact (>30 days) |
| Biocompatibility | | |
| | Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react identified. | Tested for Cytotoxicity, irritation, sensitization, accurate systematic toxicity, genotoxicity, no adverse react identified. |

Table 1 Comparison of Technology Characteristics

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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.

Substantially Equivalent (SE) Conclusion

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