(358 days)
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.
"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.
The provided text describes the 510(k) summary for the HCG Zirconia Ceramic Block, which is a dental device. The information details non-clinical testing performed to demonstrate substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria for an AI/ML-driven medical device.
Therefore, the document does not contain the requested information regarding:
- A table of acceptance criteria and reported device performance for an AI/ML device.
- Sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, ground truth types, training set sample size, or how ground truth for training data was established.
This document focuses on the physical and chemical properties, biocompatibility, and functional testing of a zirconia ceramic block against established standards (e.g., ASTM, ISO) to demonstrate its equivalence for dental restorations. It explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
In summary, this document is not a study proving an AI/ML device meets acceptance criteria. It is a submission for a dental material (zirconia block) based on non-clinical performance and substantial equivalence to existing predicate devices.
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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 (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) 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: +886-2-27925511 Fax: +886-2-27953101 Representative: CHIU-LI-CHIEN (cjhuang@hcgnet.com.tw)
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, Flexuralstrength, Chemical extraction, andCoefficient of linear expansion. | After aging, the test resultsmet the pre-defined criteriaaccording to the test standards.Thus the shelf life of thedevice is verified todemonstrate substantialequivalence. |
| ISO 6872 | |||
| Biocompatibility | ISO 10993-5 | In Vitro Cytotoxicity Test, | All the test results met thepre-defined criteria accordingto the test standards. Thus the |
| ISO 10993-4 | Hemolysis Test, Acute SystemicToxicity Study, Skin Sensitization |
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HOCHENG CORPORATION HCG Zirconia Ceramic Block
K193090
| ISO 10993-11 | Study, White RabbitIntracutaneous Reactivity Test, | biocompatibility of the deviceis verified to demonstratesubstantial equivalence. | |
|---|---|---|---|
| ISO 10993-10 | White Rabbit Pyrogen Test, | ||
| USP <151> | Muscle Implant Study, andRepeated Dose 90-Day | ||
| ISO 10993-6 | Subchronic Oral Toxicity Study inRat | ||
| Functionaltesting | ISO 6872 | Production quality of zirconiaceramic block, Size measurementof supporting shaft, and Efficacy | All the test results met thepre-defined criteria accordingto the test standards, so the |
| ISO 13356 | of the subject, predicate andreference devices (basic physicaland chemical characteristics) | efficacy of the subject deviceis verified. The comparativetesting of efficacy is also | |
| CNS 13983 | conducted on all devices, and | ||
| CNS 13958 | the test results demonstratesubstantial equivalencebetween subject, predicate andreference 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 | SubstantialEquivalenceDiscussion |
|---|---|---|---|---|
| Trade Name | HCG ZirconiaCeramic Block | NexxZr™ S andNexxZr™ T | Copran Zr/Origin YZ | |
| 510(k) No. | K193090 | K130991 | K092496 | |
| IndicationFor Use / | HCG ZirconiaCeramic Block are | NexxZr™ areintended for the | Copran Zr/ Origin YZZirconia blanks are | EquivalentAll the devices are |
| Intended Use | intended for thefabrication andpreparation ofcopings and fullanatomical/fullcontour crowns,bridges, inlays, andonlays for anteriorand posteriorsegment restorations. | fabrication andpreparation ofcopings and fullanatomical/fullcontour crowns,bridges, inlays, andonlays for anteriorand posteriorsegment restorations. | presintered blanks for CADof CAM or manual milling,made from biocompatible,tetragonal andpolycrystallinezirconiumdioxyde.Milling blanks designedfor:- Crown frameworks inthe anterior andposterior areas- Bridge frameworks inthe anterior andposterior areas- Primary conical crownsand telescopic crowns- Cantilevered bridgeswith a max. of onepontic having apremolar width- Inlays, Onlays, Veneers | zirconia blocks and usedfor preparation of dentalcrowns, bridges, inlays,and onlays. Althoughthe reference device hasmore specific usages onthe crowns, bridges andveneers, the usage scopeof subject device issmaller than that ofreference device and thesame as that of predicatedevice. Thus thedifferences betweensubject and referencedevices does not raisenew issues of SE. |
| Shape | round blocks (disks)and square blocks | disks | may be disks, cubes, bars,and cylinders. | EquivalentBoth subject device andreference device havethe same shape. |
| Maincomponent | ZrO2; Y2O3; Al2O3 | ZrO2; Y2O3; HfO2;Al2O3 | (undisclosed) | Different but meet therequirement and doesnot raise new issues ofSE. |
| Model | 8 colors(Ultra transparentlywhite, Transparently | multi colors(White, 16 A-Dshades, and 3 Bleach | multi colors(White, and multiple shadesfor Light, Medium and | EquivalentAll the devices havemulti colors of white |
| white, Light,Intermediate, Dark,Ultra-hightransparently white,Light gradient, Darkgradient) | shades) | Intense) | and customized shades.The subject device ismet the requirement andthe difference of shadesdoes not raise newissues of SE. | |
| FlexuralStrength | > 800 MPa | > 800 MPa | > 800 MPa | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Maincompliance | 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.
§ 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.