Non-Sterile Zirconia Block

K190112 · Fine Advanced Compound Co., Ltd. · EIH · Dec 20, 2019 · Dental

Device Facts

• Record ID: K190112
• Device Name: Non-Sterile Zirconia Block
• Applicant: Fine Advanced Compound Co., Ltd.
• Product Code: EIH · Dental
• Decision Date: Dec 20, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Story

Non-Sterile Zirconia Block is a dental restorative material supplied as discs; processed via CAD/CAM systems; cut and sintered to create dental restorations including crowns, veneers, and artificial teeth. Used in dental laboratories by technicians; output is a custom-milled dental prosthesis. Benefits include durable, biocompatible tooth replacement.

Clinical Evidence

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

Technological Characteristics

Zirconia ceramic blocks; Type II Class 5 per ISO 6872:2015; Tetragonal crystal morphology; Density 6.00g/cm3; Sintering temperature 1500±50°C; Non-sterile; Form factor: Discs; Intended for CAD/CAM milling.

Indications for Use

Indicated for patients requiring dental restorations, including artificial teeth in fixed or removable dentures, 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

• Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank (K180252)
• Wieland Dental + Technik GmbH & Co. KG, ZENO Zr Disc

Submission Summary (Full Text)

{0}------------------------------------------------

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 & 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.

December 20, 2019

Fine Advanced Compound Co., Ltd % Chris Park General Manager Med.com 1809 Holland Dr Somerset, New Jersey 08873

Re: K190112

Trade/Device Name: Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: November 27, 2019 Received: December 03, 2019

Dear Chris Park:

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.

{1}------------------------------------------------

termination does not mean that FDA

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) 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 mediation-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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known)

Device Name Non-Sterile Zirconia Block Model: name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+

Indications for Use (Describe)

Non-Sterile Zirconia Block (Model: Finebase, Montblanc, Trione C, Trione HT+) 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)

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

## 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: K190112

- 1. Date of Preparation: 11/20/2019
- 2. Sponsor Identification FINE ADVANCED COMPOUND Co., Ltd Address: < 7, Galgot-gil, Jinwi-myeon, Pyeongtaek-si, Gyeonggi-do, 451-862, Korea Establishment Registration Number: Not yet registered for the Number Contact Person: Jeong Kwang Ho Position: General Manger Manager Tel: [phone] Fax: [phone]

Email:<[e-mail]>

- 3. Identification of Proposed Device Trade Name: Non-Sterile Zirconia Block Common Name: Dental restorative material, porcelain powder/blocks
Regulatory Information

Classification Name: Powder, Porcelain Classification: Class II

Product Code: EIH Regulation Number: 872.6660

Review Panel: Dental Indication for Use Statement: Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

Device Description

Non-Sterile Zirconia Block (Model name: Finebase, Montblanc, Trione HT, Trione C, Trione HT+) is a manufacture unit that is cut, processed and sintered by CAD/CAM system of the computers designed for production of dental restoration.

- 4. Identification of Predicate Device(s)
Primary predicate

- 510(k) number: K180252
- Company: Crown Porcelain Dental Technology Co., Ltd.
- Model: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
- Wieland Dental + Technik GmbH & Co. KG, ZENO Zr Disc
- Classification: Class II

{4}------------------------------------------------

- Non-Clinical Test Conclusion న్.
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. A
- > Density Test
- > Cytotoxicity per ISO 10993-5:2009;
- > Intracutaneous Reactivity Test per ISO 10993-10:2010;
- > Sensitization Test per ISO 10993-10:2010
- Acute Systematic Toxicity per ISO 10993-11:2006; >
- > Genotoxicity Tests per ISO 10993-3:2014.
- 6. Clinical Test Conclusion

No clinical study is included in this submission.

- 7. Substantially Equivalent (SE) Comparison

{5}------------------------------------------------

510(k) Summary

| ITEM | Non-Sterile Zirconia Block<br>(Model name: Finebase,<br>Montblanc, Trione HT, Trione<br>C, Trione HT+) | Primary Predicate<br>K180252 | Differences |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Product Code | EIH | EIH | None |
| Regulation<br>Number | 872.6660 | 872.6660 | Same |
| Indication for use | Non-Sterile Zirconia Block<br>(Model name: Finebase,<br>Montblanc, Trione HT, Trione<br>C, Trione HT+) are indicated<br>for the production of artificial<br>teeth in fixed or removable<br>dentures, or for jacket<br>crowns, facings, and veneers. | Crown Dental Zirconia Blank &<br>Crown Dental Zirconia Pre-<br>Shaded Blank are indicated for<br>the production of artificial teeth<br>in fixed or removable dentures,<br>or for jacket crowns, facings,<br>and veneers. | Indication for use is same as<br>predicates. |
| Feature | Colored | Colored | Same |
| Shape | Discs | Discs | Same |
| Type and Class<br>per ISO 6872:<br>2015 | Type II Class 5 | Type II Class 5 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Crystal<br>Morphology | Tetragonal | Tetragonal | Same |
| Density | $6.00g/cm^3$ | $6.00g/cm^3$ | Same |
| Sintering<br>temperature | $1500±50°C$ | $1500±50°C$ | Same |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 | Same |
| Contact Level | surface device with permanent<br>contact | surface device with permanent<br>contact | Same |
| Biocompatibility | Tested for Cytotoxicity,<br>irritation, sensitization,<br>accurate systematic toxicity,<br>genotoxicity, no adverse react | Tested for Cytotoxicity,<br>irritation, sensitization, accurate<br>systematic toxicity, genotoxicity,<br>no adverse react | Same |

{6}------------------------------------------------

510(k) Summary

Subject device, Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank is very similar to the predicate device.

### 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.