(358 days)
No
The summary describes a ceramic block for dental restorations and its physical properties and testing, with no mention of AI or ML.
No.
The device is a material (ceramic block) used for fabricating dental restorations, not a device that directly provides a therapeutic benefit to the patient. It's an input material for medical devices.
No
The HCG Zirconia Ceramic Block is intended for the fabrication of dental restorations (copings, crowns, bridges, inlays, onlays) and is described as a material for manufacturing these items, not for diagnosing conditions.
No
The device is a physical ceramic block, not software. The description explicitly states it is composed of zirconia compounds and is used for fabricating dental restorations.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the fabrication of dental restorations (copings, crowns, bridges, inlays, and onlays). This is a structural and restorative purpose, not a diagnostic one.
- Device Description: The description confirms it's a ceramic block for manufacturing dental prosthetics.
- Lack of Diagnostic Elements: There is no mention of the device being used to test samples from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Performance Studies: The performance studies focus on material properties (shelf life, biocompatibility, flexural strength) relevant to a dental restorative material, not diagnostic accuracy.
IVD devices are specifically designed to perform tests on biological samples to provide diagnostic information. This device is a material used to create a physical restoration within the mouth.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
"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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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 Testing:
Shelf life: ASTM F1980, ISO 6872. Acceptance criteria: Visual inspection, Flexural strength, Chemical extraction, and Coefficient of linear expansion. Result: After aging, the test results met the pre-defined criteria according to the test standards. Thus the shelf life of the device is verified to demonstrate substantial equivalence.
Biocompatibility: ISO 10993-5, ISO 10993-4, ISO 10993-11, ISO 10993-10, USP , ISO 10993-6. Acceptance criteria: In Vitro Cytotoxicity Test, Hemolysis Test, Acute Systemic Toxicity Study, Skin Sensitization Study, White Rabbit Intracutaneous Reactivity Test, White Rabbit Pyrogen Test, Muscle Implant Study, and Repeated Dose 90-Day Subchronic Oral Toxicity Study in Rat. Result: All the test results met the pre-defined criteria according to the test standards. Thus the biocompatibility of the device is verified to demonstrate substantial equivalence.
Functional testing: ISO 6872, ISO 13356, CNS 13983, CNS 13958. Acceptance criteria: Production quality of zirconia ceramic block, Size measurement of supporting shaft, and Efficacy of the subject, predicate and reference devices (basic physical and chemical characteristics). Result: All the test results met the pre-defined criteria according to the test standards, so the efficacy of the subject device is verified. The comparative testing of efficacy is also conducted on all devices, and the test results demonstrate substantial equivalence between subject, predicate and reference devices.
No clinical test data was used to support the decision of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
1
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
2
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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3
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 & |
4
| 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 | |
| strength, Chemical extraction, and | |||
| Coefficient of linear expansion. | After aging, the test results | ||
| met the pre-defined criteria | |||
| according to the test standards. | |||
| Thus the shelf life of the | |||
| device is verified to | |||
| demonstrate substantial | |||
| equivalence. | |||
| ISO 6872 | |||
| Biocompatibility | ISO 10993-5 | In Vitro Cytotoxicity Test, | All the test results met the |
| pre-defined criteria according | |||
| to the test standards. Thus the | |||
| ISO 10993-4 | Hemolysis Test, Acute Systemic | ||
| Toxicity Study, Skin Sensitization |
5
HOCHENG CORPORATION HCG Zirconia Ceramic Block
K193090
| | ISO 10993-11 | Study, White Rabbit
Intracutaneous Reactivity Test, | biocompatibility of the device
is verified to demonstrate
substantial equivalence. |
|-----------------------|--------------|--------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| | ISO 10993-10 | White Rabbit Pyrogen Test, | |
| | USP | Muscle Implant Study, and
Repeated Dose 90-Day | |
| | ISO 10993-6 | Subchronic Oral Toxicity Study in
Rat | |
| Functional
testing | ISO 6872 | Production quality of zirconia
ceramic block, Size measurement
of supporting shaft, and Efficacy | All the test results met the
pre-defined criteria according
to the test standards, so the |
| | ISO 13356 | of the subject, predicate and
reference devices (basic physical
and chemical characteristics) | efficacy of the subject device
is verified. The comparative
testing of efficacy is also |
| | CNS 13983 | | conducted on all devices, and |
| | CNS 13958 | | the test results demonstrate
substantial equivalence
between subject, predicate and
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
Equivalence
Discussion |
|-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Trade Name | HCG Zirconia
Ceramic Block | NexxZr™ S and
NexxZr™ T | Copran Zr/Origin YZ | |
| 510(k) No. | K193090 | K130991 | K092496 | |
| Indication
For Use / | HCG Zirconia
Ceramic Block are | NexxZr™ are
intended for the | Copran Zr/ Origin YZ
Zirconia blanks are | Equivalent
All the devices are |
| Intended Use | intended for the
fabrication and
preparation of
copings and full
anatomical/full
contour crowns,
bridges, inlays, and
onlays for anterior
and posterior
segment restorations. | fabrication and
preparation of
copings and full
anatomical/full
contour crowns,
bridges, inlays, and
onlays for anterior
and posterior
segment restorations. | presintered blanks for CAD
of CAM or manual milling,
made from biocompatible,
tetragonal and
polycrystalline
zirconiumdioxyde.
Milling blanks designed
for:
- Crown frameworks in
the anterior and
posterior areas - Bridge frameworks in
the anterior and
posterior areas - Primary conical crowns
and telescopic crowns - Cantilevered bridges
with a max. of one
pontic having a
premolar width - Inlays, Onlays, Veneers | zirconia blocks and used
for preparation of dental
crowns, bridges, inlays,
and onlays. Although
the reference device has
more specific usages on
the crowns, bridges and
veneers, the usage scope
of subject device is
smaller than that of
reference device and the
same as that of predicate
device. Thus the
differences between
subject and reference
devices does not raise
new issues of SE. |
| Shape | round blocks (disks)
and square blocks | disks | may be disks, cubes, bars,
and cylinders. | Equivalent
Both subject device and
reference device have
the same shape. |
| Main
component | ZrO2; Y2O3; Al2O3 | ZrO2; Y2O3; HfO2;
Al2O3 | (undisclosed) | Different but meet the
requirement and does
not raise new issues of
SE. |
| Model | 8 colors
(Ultra transparently
white, Transparently | multi colors
(White, 16 A-D
shades, and 3 Bleach | multi colors
(White, and multiple shades
for Light, Medium and | Equivalent
All the devices have
multi colors of white |
| | white, Light,
Intermediate, Dark,
Ultra-high
transparently white,
Light gradient, Dark
gradient) | shades) | Intense) | and customized shades.
The subject device is
met the requirement and
the difference of shades
does not raise new
issues of SE. |
| Flexural
Strength | > 800 MPa | > 800 MPa | > 800 MPa | Same |
| Sterile | Non-sterile | Non-sterile | Non-sterile | Same |
| Main
compliance | ISO 6872 | ISO 6872 | (undisclosed) | Same |
6
HOCHENG CORPORATION HCG Zirconia Ceramic Block
K193090
7
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.