Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the material and manufacturing process using a standard CAD/CAM system, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

No
This device is a zirconia block used for manufacturing dental restorations, not a device that directly provides therapy.

Diagnostic

No

The device is a material (zirconia block) used for manufacturing dental restorations, not for diagnosing medical conditions. Its described purpose is the "production of artificial teeth."

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "manufacture unit" that is "cut, processed and sintered" by a CAD/CAM system, indicating it is a physical material (zirconia block) used in a manufacturing process, not a software-only device. The performance studies also focus on material properties and biocompatibility tests, not software validation.

IVD (In Vitro Diagnostic)

No, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the production of artificial teeth and dental restorations. This is a manufacturing process for a medical device that will be implanted or used in the mouth, not a test performed on a sample taken from the body to diagnose a condition.
Device Description: The device is a material (zirconia block) used in a manufacturing process (CAD/CAM system) to create dental prosthetics. It doesn't perform any diagnostic function.
Performance Studies: The performance studies listed are related to the material properties and biocompatibility of the zirconia block, not the diagnostic accuracy of a test.
Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting biomarkers, or providing diagnostic information about a patient's health status.

This device falls under the category of a dental prosthetic material used in the manufacturing of medical devices for dental restoration.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

EIH

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

artificial teeth (in fixed or removable dentures), jacket crowns, facings, and veneers.

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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;
Sensitization Test per ISO 10993-10:2010
Acute Systematic Toxicity per ISO 10993-11:2006;
Genotoxicity Tests per ISO 10993-3:2014.
No clinical study is included in this submission.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K180252

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 872.6660 Porcelain powder for clinical use.

(a)
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.(b)
Classification. Class II.

Summary

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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 & 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.

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

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)

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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
1. Sponsor Identification FINE ADVANCED COMPOUND Co., Ltd Address:
1. 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.

1. 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

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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.
1. Clinical Test Conclusion

No clinical study is included in this submission.

1. Substantially Equivalent (SE) Comparison

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510(k) Summary

| ITEM | Non-Sterile Zirconia Block
(Model name: Finebase,
Montblanc, Trione HT, Trione
C, Trione HT+) | Primary Predicate
K180252 | Differences |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------|
| Product Code | EIH | EIH | None |
| Regulation
Number | 872.6660 | 872.6660 | Same |
| Indication for 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. | 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. | Indication for use is same as
predicates. |
| Feature | Colored | Colored | Same |
| Shape | Discs | Discs | Same |
| Type and Class
per ISO 6872:
2015 | Type II Class 5 | Type II Class 5 | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Crystal
Morphology | Tetragonal | Tetragonal | Same |
| Density | $6.00g/cm^3$ | $6.00g/cm^3$ | Same |
| Sintering
temperature | $1500±50°C$ | $1500±50°C$ | Same |
| Performance | Comply with ISO 6872 | Comply with ISO 6872 | Same |
| Contact Level | surface device with permanent
contact | surface device with permanent
contact | Same |
| Biocompatibility | Tested for Cytotoxicity,
irritation, sensitization,
accurate systematic toxicity,
genotoxicity, no adverse react | Tested for Cytotoxicity,
irritation, sensitization, accurate
systematic toxicity, genotoxicity,
no adverse react | Same |

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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.