(272 days)
Not Found
No
The device description and performance studies focus on the material properties and manufacturing process of a zirconia-based ceramic for dental prosthetics, with no mention of AI or ML.
No
The device is a material used in the manufacture of dental prosthetics, not a device that directly treats or prevents disease or affects the structure or function of the body for therapeutic purposes.
No
The device is a material used in the manufacturing of dental prosthetics, not for diagnosing medical conditions.
No
The device description clearly states it is a zirconia-based ceramic material provided in various shapes, indicating it is a physical material, not software. The performance studies also focus on material properties.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "used in the manufacture of dental prosthetics." This is a manufacturing material for a medical device (dental prosthetics), not a device used to perform a diagnostic test on a biological sample.
- Device Description: The description details a zirconia-based ceramic material used for creating dental restorations through a manufacturing process (cutting by CAD/CAM systems). It does not describe a device that analyzes biological samples to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing information for the diagnosis, monitoring, or prognosis of a disease or condition.
The device is clearly a material used in the fabrication of a medical device (dental prosthetics), which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Zmaxx T Series is used in the manufacture of dental prosthetics.
Product codes (comma separated list FDA assigned to the subject device)
EIH
Device Description
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
Zmaxx T Series offers various types as follows: W-type, T-type, Z-type, A-type, C-type, B-type, K-type, and Q-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. User can choose a type which fits the jig they have.
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)
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- · ISO 6872 Freedom of Extraneous Materials , Radiation Emission , Flexural Strength,
- · Thermal Expansion Coefficient, Chemical Solubility, Density, Shrinkage Factor
- · ISO 13356 Mono Clinic Phrase Rate
- · ISO 10993-5 Cytotoxicity
- · ISO 10993-10 Sensitization & Irritation
- · ISO 10993-11 Acute Systemic Toxicity
- · Other bench testing Visual Inspection, Dimension Accuracy, Package, Uniformity
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.
Not Found
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, stacked on top of each other. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 26, 2017
Maxx Digm, Inc. Priscilla Chung Regulatory Affairs Consultant LK Consulting Group USA, Inc. 800 Roosevelt Ste 417 Irvine, California 92620
Re: K161219
Trade/Device Name: Zmaxx T Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: April 28, 2016 Received: April 29, 2016
Dear Priscilla Chung:
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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
Page 2 - Priscilla Chung
the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Susan Russo, DDS, MA
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Zmaxx T Series
Indications for Use (Describe)
Zmaxx T Series is used in the manufacture of dental prosthetics.
| 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) |
| | 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
(K161219)
This summary of 510(k) is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: _ December 27, 2016
Applicant / Submitter: 1.
Maxx Digm, Inc.
3265 Kifer Road Santa Clara, CA 95051
Tel: 408-462-9608 Fax: 408-542-9871
2. Submission Correspondent:
Priscilla Chung LK Consulting Group USA, Inc. 800 Roosevelt Ste 417, Irvine CA 92620 Fax: 714-409-3357 Phone: 714-202-5789 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Zmaxx T Series |
|---|---|
| Common Name: | Dental Frame Material for Dental Prosthesis |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
4. Predicate Device:
Primary Predicate Device: NATURAZ SERIES (K091096) by The Dental Solutions, Inc. Reference Predicate Device: BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc.
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5. Device Description:
Zmaxx T Series is zirconia-based ceramic provided in various shapes such as round and square and it is used to manufacture cores of all ceramic crowns, and is classified into ISO 6872 Type 2 Class 4. It is used to manufacture ceramic restorations through cutting process by dental MAD/MAM, computer-assisted design system, or CAD/CAM system. The subject device offers three different shades to meet the needs of different patients tooth colors. It also offers various shape types to be used with various jigs for CAD/CAM milling machine.
Zmaxx T Series offers various types as follows: W-type, T-type, Z-type, A-type, C-type, B-type, K-type, and Q-type. These different types are to accommodate the different types of the jig that is built-in CAD/CAM machine. User can choose a type which fits the jig they have.
| Type | Size Range | Weight Range |
|---|---|---|
| W-type | 98.5mm(D) x 10-25mm(T) | 250-580g |
| T-type | 100mm(D) x 10-25mm(T) | 250-615g |
| D-type | 98mm(D) x 10-25mm(T) | 250-595g |
| Z-type | 95mm(D) x 10-30mm(T) | 230-700g |
| A-type | 90mm(W)×73mm(L)×12-25mm(H) | 210-420g |
| C-type | 15.5-22mm(W)×19-25(L)×20-65(H) | 20-125g |
| B-type | 65(W)×35(L)×12-22mm(H) | 85-155g |
| K-type | 75(W)×45(L)×12-22mm(H) | 127-260g |
| Q-type | 100(W)×100(L)×12-22mm(H) | 380-665g |
6. Indications for Use:
Zmaxx T Series is used in the manufacture of dental prosthetics.
7. Performance Data(Non-Clinical):
The following properties were tested based on the referenced standards. All the test results support substantial equivalence to the predicate devices.
- · ISO 6872 Freedom of Extraneous Materials , Radiation Emission , Flexural Strength,
- · Thermal Expansion Coefficient, Chemical Solubility, Density, Shrinkage Factor
- · ISO 13356 Mono Clinic Phrase Rate
- · ISO 10993-5 Cytotoxicity
- · ISO 10993-10 Sensitization & Irritation
- · ISO 10993-11 Acute Systemic Toxicity
- · Other bench testing Visual Inspection, Dimension Accuracy, Package, Uniformity
8. Substantial Equivalence
The Zmaxx T Series is substantially equivalent to the NATURAZ SERIES (K091096) by The Dental Solutions, Inc. and BruxZir™ Anterior (K143330) by Prismatik Dentalcraft, Inc. The following comparison table is presented to demonstrate substantial equivalence. They share the similar
5
material and similar physical / chemical properties. However, the mixing ratios of the raw materials are different between the devices.
Despite these differences, the performance test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate devices in physical and chemical properties and meets the necessary requirements. In addition, the subject device has been tested for cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), irritation (ISO 10993-10), and acute systemic toxicity (ISO 10993-11) to meet the biocompatibility requirements.
Based on the comparison between the two devices and the performance testing results presented in this 510K, we conclude that the Zmaxx T Series is substantially equivalent to the predicate devices.
| Subject Device | Primary Predicate Device | Reference Predicate Deice | |
|---|---|---|---|
| 510(k) Number | K161219 | K091096 | K143330 |
| Device Name | Zmaxx T Series | NATURAZ SERIES | BruxZir™ Anterior |
| Common Name | Porcelain, Powder for | ||
| clinical use | Porcelain, Powder for clinical | ||
| use | Porcelain, Powder for clinical | ||
| use | |||
| 510k Applicant | Maxx Digm, Inc. | The Dental Solutions, Inc. | Prismatik Dentalcraft, Inc. |
| Contract | |||
| Manufacturer | DMAX Co. Ltd. | DMAX Co., Ltd. | |
| Indication For Use | Zmaxx T Series is used in | ||
| the manufacture of dental | |||
| prosthetics. DMAX CO., | |||
| LTD proposes that the | |||
| materials distributed within | |||
| the United States be labeled | NaturaZ Series is used in the | ||
| manufacture of dental | |||
| prosthetics. The Dental | |||
| Solution, Inc. proposes that | |||
| the materials distributed | |||
| within the United States be | |||
| labeled: | |||
| "Caution: Federal (US) law | |||
| restricts the sale of the device | |||
| to, or on the order of, licensed | |||
| professionals." | The device is indicated for use | ||
| by dental technicians in the | |||
| construction of custom | |||
| made all ceramic restorations | |||
| for anterior and posterior | |||
| location. | |||
| CTE(coefficient of | |||
| thermal expansion | $(10.6±0.5)×10^{-6}K^{-1}$ | ||
| (meeting the ISO 6872 | |||
| requirement) | $(11.5±0.5)×10^{-6}K^{-1}$ | ||
| (meeting the ISO 6872 | |||
| requirement) | $11 ×10^{-6}K^{-1}$ | ||
| (meeting the ISO 6872 | |||
| requirement) | |||
| Flexural strength | >600MPa | ||
| (meeting the ISO 6872 | |||
| requirement) | >800MPa | ||
| (meeting the ISO 6872 | |||
| requirement) | >650MPa | ||
| (meeting the ISO 6872 | |||
| requirement) | |||
| Chemical solubility | $ |