(177 days)
Not Found
No
The 510(k) summary describes a dental ceramic material (lithium silicate) used for fabricating restorations via CAD/CAM milling or hot press techniques. There is no mention of AI or ML in the intended use, device description, performance studies, or any other section. The focus is on the material properties and fabrication methods.
No.
This device is a dental material used for fabricating restorations such as crowns, veneers, inlays, and onlays, which are primarily for restorative and aesthetic purposes, not for treating a disease or condition.
No
Explanation: The device is a dental material (lithium silicate ceramic) used for fabricating restorations like crowns and veneers. It is a material used in treatment, not for diagnosing conditions.
No
The device description clearly states that the device is a lithium silicate ceramic supplied in the form of Ingots & Blocks, which are physical materials, not software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for fabricating dental restorations (crowns, veneers, inlays/onlays, bridges) using CAD/CAM or hot press techniques. This is a manufacturing process for a medical device that is implanted or placed in the body, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a lithium silicate ceramic material in the form of ingots and blocks. It's a material used to create the final restoration.
- Lack of Diagnostic Activity: There is no mention of the device being used to test samples (blood, urine, tissue, etc.) or to provide information about a patient's health status or disease.
IVD devices are specifically designed to perform tests on samples from the human body to provide diagnostic information. This device is a material used to create a dental prosthesis.
N/A
Intended Use / Indications for Use
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.
Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
Product codes
EIH
Device Description
Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique.
This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.
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 Uniformity, Foreign Body, Chemical Solubility, Flexural Strength, . Radioactivity, Linear Thermal Expansion, Glass Transition Temperature tests
- . ISO 10993-3 - Genotoxicity
- ISO 10993-5 Cytotoxicity י
- ISO 10993-10 Sensitization & Irritation .
- ISO 10993-11 Systemic Toxicity(oral) .
- Other bench testing Visual Inspection, Size, Package tests י
Test Results:
- Visual Inspection: There were no extraneous materials, distributing at use when assessed by visual inspection.
- Size Test: PASS (The size tolerance should be within +/- 2mm)
- Package Test: There was no breakage, no crack, no pollution of foreign body and no problem of use in product.
- Uniformity Test: Colorants were dispersed uniformly on the block.
- Foreign Body Test: They were free from extraneous materials.
- Chemical Solubility Test: PASS (less than 100 ug/cm²)
- Flexural Strength Test: PASS (Over 300 MPa)
- Radioactivity Test: PASS (U238: Less than 1.0 Bq/g)
- Linear Thermal Expansion Test: PASS (10.0+/- 0.5 10-6K-1)
- Glass Transition Temperature Test: PASS (550+/- 20 °C)
- Genotoxicity: PASS (= 70%)
- Irritation test: PASS (No mutation)
- Sensitization test: PASS (
§ 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.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 14, 2016
Hass Corp. Ms. Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group Usa, Inc. 2651 E Chapman Ave Ste 110 Fullerton, California 92831
Re: K160102
Trade/Device Name: Amber Mill Series And Amber Press Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: January 12, 2016 Received: January 19, 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
the quality systems (OS) 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 yours,
Michael J. Ryan -S
for Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control. and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K160102
Device Name
Amber Mill Series and Amber Press Series
Indications for Use (Describe)
Amber Mill Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using CAD/CAM System.
Amber Press Series are indicated for fabricating glass ceramic restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges using hot press technique.
| 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 (K160102)
This summary of 510(k)-safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: ___ July 12, 2016_____
1. Applicant / Submitter:
HASS CORP. 77-14, Gwahakdanji-ro Gangneung-si, Gangwon-do, Republic of Korea, 210-340
Tel: +82-70-7712-1300 Fax: +82-33-644-1231
Submission Correspondent: 2.
Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110, Fullerton, CA 92831 Phone: 714-202-5789 Fax: 714-409-3357 Email: juhee.c@lkconsultinggroup.com
3. Device:
| Proprietary Name: | Amber Mill Series and Amber Press Series |
|---|---|
| Common Name: | Dental Frame Material for Dental Prosthesi |
| Classification Name: | Porcelain Powder for Clinical Use |
| Classification: | Class II, 21 CFR 872.6660 |
| Classification Product Code: | EIH |
4. Predicate Device:
Obsidian™ Milling Blocks by Prismatik Dentalcraft, Inc. (K141788) Obsidian™ Press(All-Ceramic and POM) by Prismatik Dentalcraft, Inc. (K141887)
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5. Device Description:
Amber Mill Series and Amber Press Series are a lithium silicate ceramic to be supplied in the form of Ingots & Blocks. Amber Mill can be fabricated using CAD/CAM technologies and Amber Press can be fabricated using hot press technique.
This dental material is glass type material used for aesthetic purposes of veneers, inlay/onlay, partial crowns, anterior crowns, posterior crowns. The ceramics material is composed of SiO2, Li20, K20, P205, Al2O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface.
The subject device offers 31 different size/shape series and each series offers 45 different shades. 31 different sizes are to be used with various equipments for CAD/CAM milling or hot press and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patients tooth colors.
6. Principles of Operation:
Amber Mill Series and Amber Press Series are glass type dental material which can be fabricated using CAD/CAM technologies or hot press technique to make restorations such as single-unit anterior and posterior crowns, veneers, inlays/onlays, and anterior 3-unit bridges not involving molar restoration. These blanks correspond to ISO 6872, Dentistry: Ceramic Materials. The subject devices offer various sizes and shades to meet the needs of different patients' tooth shapes and colors.
| Material | Glass Ceramic |
|---|---|
| Category | Dental Frame Material for Dental Prosthesis |
| Color | Various (High , Low translucencies and Medium Opacity): 16 A-D and |
| 4 Bleach W shades | |
| Odor | Odorless |
| Flexural strength | > 300MPa |
| Chemical solubility | 300MPa |
| (meeting the ISO6872 | |
| requirements) | > 300MPa |
| (meeting the ISO6872 | |
| requirements) | > 300MPa |
| (meeting the ISO6872 | |
| requirements) | Similar |
| ** All devices meet ISO | |
| 6872 requirements. | |
| Chemical | |
| solubility |