(135 days)
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No
The summary describes a material (zirconia blanks) used for dental prosthetics and focuses on its physical and biological properties, with no mention of AI or ML in the device description, intended use, or performance studies.
No.
The device is used for the production of artificial teeth, which are restorative and not therapeutic in nature. The intended use does not describe a mechanism to treat or alleviate a disease or condition.
No
Explanation: The device, ZMAXX Dental Zirconia Blanks, is indicated for the production of artificial teeth. Its function is to create dental prosthetics, not to diagnose medical conditions or diseases.
No
The device description clearly indicates it is a physical product (Dental Zirconia Blanks) used for creating artificial teeth, not a software application.
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, which are used in the body (in the mouth) as part of a dental prosthesis.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) outside of the body to provide information about a person's health.
- Device Description: The description clearly indicates it's a material (zirconia blanks) used to fabricate dental restorations.
- Performance Studies: The performance studies listed are related to the material properties and biocompatibility of the zirconia, not diagnostic performance on biological samples.
This device is a dental material used for fabrication, not a diagnostic tool.
N/A
Intended Use / Indications for Use
ZMAXX Dental Zirconia Blanks 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
Dental Zirconia Blank is available in various specifications, which are combinations of height (1225mm), color model (0M1/A1 A3/B1B4/C1C4/D2~D4) and transparency model (T45).
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
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: 2015, Dentistry-Ceramic materials
- Density Test
- Cytotoxicity per ISO 7405:2008;
- 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
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that 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.
November 1, 2019
ZMAXX Bioceramics LLC % Ying Xu General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CHINA
Re: K191631
Trade/Device Name: ZMAXX Dental Zirconia Blanks Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: Class II Product Code: EIH Dated: August 9, 2019 Received: August 23, 2019
Dear Ying Xu:
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
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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 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 Nandkumar, Ph.D. Acting 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 ZMAXX Dental Zirconia Blanks
Indications for Use (Describe)
ZMAXX Dental Zirconia Blanks 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: _K191631
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- Date of Preparation: 05/10/2019
- Sponsor Identification 2.
ZMAXX BIOCERAMICS LLC
231 PELICAN CT FOSTER CITY, CA 94404
Establishment Registration Number: Not yet registered for the Number
Contact Person: Josef Wu Position: General Manager Tel: +1-510-774-1317 Email: raywheel.trading@gmail.com
-
- Designated Submission Correspondent
Ms. Diana Hong (Primary Contact Person) Ms. Jing Cheng (Alternative Contact Person)
- Designated Submission Correspondent
Mid-Link Consulting Co., Ltd P.O. Box 120-119, Shanghai, 200120, China
Tel: +86-21-22815850, Fax: +1(0)360 925-3199 Email: info@mid-link.net
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4. Identification of Proposed Device
Trade Name: ZMAXX Dental Zirconia Blanks Common Name: Zirconia Blocks
Regulatory Information
Classification Name: Powder, Porcelain Classification: II Product Code: EIH Regulation Number: 872.6660 Review Panel: Dental
Indication for Use:
ZMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.
Device Description
Dental Zirconia Blank is available in various specifications, which are combinations of height (1225mm), color model (0M1/A1 A3/B1B4/C1C4/D2~D4) and transparency model (T45).
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- Identification of Predicate Device
510(k) Number: K160367 Product Name: Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Manufacturer: Nissin-Metec China Co., Ltd
- Identification of Predicate Device
-
- Non-Clinical Test Conclusion
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
- Non-Clinical Test Conclusion
-
Performance Test per ISO 6872: 2015, Dentistry-Ceramic materials
-
Density Test
-
Cytotoxicity per ISO 7405:2008;
-
Intracutaneous Reactivity Test per ISO 10993-10:2010;
-
Sensitization Test per ISO 10993-10:2010
-
Acute Systematic Toxicity per ISO 10993-11:2006;
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- ♪ Genotoxicity Tests per ISO 10993-3:2014.
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- Clinical Test Conclusion
No clinical study is included in this submission.
- Substantially Equivalent (SE) Comparison 8.
| Table 1 Comparison of Technology Characteristics | |||
|---|---|---|---|
| -- | -- | -- | -------------------------------------------------- |
| ITEM | Subject Device | Predicate Device K160367 |
|---|---|---|
| Product Code | EIH | EIH |
| Regulation Number | 872.6660 | 872.6660 |
| Indication for Use | ZAMAXX Dental Zirconia Blanks are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers. | Nissin Dental Zirconia Blank & 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. |
| Feature | Colored | Uncolored and Colored |
| Shape | discs | Semic, Rods, Blocks and Dics |
| Type and Class per ISO 6872 | Type II Class 5 | Type II Class 5 |
| Sterility | Non-Sterile | Non-sterile |
| Chemical Composition | ||
| (Weight %) | ZrO2 >99.0% | |
| Inorganic Pigment | ||
| (Al2O3, SiO2, Fe2O3, Er2O3) 30 days) | surface device with permanent | |
| contact (>30 days) | ||
| Biocompatibility | Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react | Tested for Cytotoxicity, irritation, sensitization, systematic toxicity, genotoxicity, no adverse react identified |
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| identified. | |||
|---|---|---|---|
| -- | -- | ------------- | -- |
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.
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- Substantially Equivalent (SE) Conclusion 9.
Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate device.