(330 days)
No
The device description focuses on the material composition and physical properties of dental ceramic blocks used with CAD/CAM technology, with no mention of AI or ML.
No.
The device is a restorative material (lithium disilicate ceramic blocks) used to fabricate prosthetic restorations for dental purposes, such as crowns, veneers, inlays, and onlays, and does not provide therapy.
No
The device is a ceramic material intended for fabricating prosthetic dental restorations (inlays, onlays, veneers, crowns) for aesthetic purposes, not for diagnosing medical conditions.
No
The device description clearly states the device is a lithium disilicate ceramic supplied in the form of blocks, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for creating dental restorations (inlays, onlays, veneers, partial crowns, and crowns) for natural and implant-supported teeth. This is a therapeutic/restorative use, not a diagnostic one.
- Device Description: The device is a material (lithium disilicate ceramic blocks) used to fabricate these restorations. It's a physical component for dental prosthetics.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the human body (blood, urine, tissue, etc.) or to provide information about a patient's health status, disease, or condition.
- Performance Studies and Metrics: The performance studies and metrics focus on the physical and chemical properties of the material (flexural strength, solubility, etc.) and its biocompatibility, which are relevant to its use as a dental restorative material, not a diagnostic tool.
IVD devices are specifically designed to perform tests on biological samples to diagnose, monitor, or screen for diseases or conditions. This device does not fit that description.
N/A
Intended Use / Indications for Use
Once finalized into a suitable design, the Amber Mill O Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
Product codes
EIH
Device Description
Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the form of Blocks. Amber Mill O Series & Amber Mill Direct Series can be fabricated using CAD/CAM technologies. The subject devices are intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne teeth. The subject devices are glass type material used for aesthetic purposes of veneers, inlays, onlays, single-unit anterior and posterior crowns.
The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 18 different size/shape series and each series offers 45 different shades. 18 different sizes are to be used with various equipment for CAD/CAM milling and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patient's tooth colors. The subject devices don't need sintering since they are provided fully crystallized.
The only difference between Amber Mill Q Series and Amber Mill Direct Series is that the Amber Mill Q series has a hole in the center combined with a zirconia cap. The holes in Amber Mill Q are sizes compatible with abutment, through which are bonded to abutment to be connected to the implant.
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
Performance Tests including Flexural strength, Chemical solubility, Freedom from Extraneous Material, Radioactivity, Linear of thermal expansion, Glass Transition Temperature in accordance with ISO 6872
Biocompatibility tests in accordance with ISO 10993-5, 10, and 11.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
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August 26, 2021
HASS Corp. % Priscilla Chung Regulatory Affairs Consultant Lk Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, California 92620
Re: K202952
Trade/Device Name: Amber Mill Q Series & Amber Mill Direct Series Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder For Clinical Use Regulatory Class: Class II Product Code: EIH Dated: May 19, 2021 Received: May 28, 2021
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. 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
1
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 (OS) 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 mediation-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 Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT 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) K202952
Device Name
Amber Mill Q Series & Amber Mill Direct Series
Indications for Use (Describe)
Once finalized into a suitable design, the Amber Mill O Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
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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3
510(k) Summary
(K202952)
This summary of 510(K) information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: 8/9/2021
1. Submitter
HASS CORP. 77-14. Gwahakdanji-ro Gangneung-si, Gangwon-do, Republic of Korea, 25452
Tel: +82-70-7712-1300 Fax: +82-33-644-1231
2. U.S Agent/Contact Person
Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200, Irvine CA 92620 Phone: 714.202.5789 Fax: 714-409-3357 Email: juhee.c(@lkconsultinggroup.com
3. Device
- . Trade Name: Amber Mill Q Series & Amber Mill Direct Series
- Common Name: Dental Frame Material for Dental Prosthesis
- Classification Name: Porcelain Powder for Clinical Use ●
- Product Code: EIH
- . Classification regulation: 21 CFR 872.6660
4. Primary Predicate Device:
Straumann n!ce Glass-Ceramic Blocks by Institut Straumann AG (K160262)
5. Description:
Amber Mill Q Series and Amber Mill Direct Series are a lithium disilicate ceramic to be supplied in the form of Blocks. Amber Mill O Series & Amber Mill Direct Series can be fabricated using CAD/CAM technologies. The subject devices are intended to be milled to produce prosthetic restorations for natural and endosseous dental implant abutment borne
4
teeth. The subject devices are glass type material used for aesthetic purposes of veneers, inlays, onlays, single-unit anterior and posterior crowns.
The ceramics material is composed of SiO2, Li2O, K2O, P2O5, A12O3 and other oxides. It also contains inorganic pigments to provide different shades on the product surface. The subject device offers 18 different size/shape series and each series offers 45 different shades. 18 different sizes are to be used with various equipment for CAD/CAM milling and to meet the needs of patients' various tooth shapes. 45 different shades are offered to meet the needs of different patient's tooth colors. The subject devices don't need sintering since they are provided fully crystallized.
The only difference between Amber Mill Q Series and Amber Mill Direct Series is that the Amber Mill Q series has a hole in the center combined with a zirconia cap. The holes in Amber Mill Q are sizes compatible with abutment, through which are bonded to abutment to be connected to the implant.
The CAD/CAM systems and abutments compatible with Amber Mill Q series are as follows :
| CAD/CAM System: | Sirona Dental CAD/CAM system (K193408) |
|---|---|
| Abutment: | Sirona TiBase (K193408) |
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6. Indication for use:
Once finalized into a suitable design, the Amber Mill Q Series and Amber Mill Direct Series are indicated for use as inlays, onlays, veneer, partial crowns and crowns.
7. Basis for Substantial Equivalence
Amber Mill Q Series and Amber Mill Direct Series are substantially equivalent to the Straumann n!ce Glass-Ceramic (K160262) The following comparison table is presented to demonstrate substantial equivalence.
| Proposed Device | Primary Predicate Device | Comparison Discussion | |
|---|---|---|---|
| 510(k) Number | K202952 | K160262 | Equivalent |
| Device Name | Amber Mill Q Series and | ||
| Amber Mill Direct Series | Straumann n!ce Glass-Ceramic | ||
| Blocks | - | ||
| Common Name | Porcelain powder for clinical | ||
| use | Porcelain powder for clinical | ||
| use | - | ||
| Manufacturer | HASS CORP. | Institut Straumann AG | - |
| Indication For Use | Once finalized into a suitable | ||
| design, the Amber Mill Q | |||
| Series and Amber Mill Direct | |||
| Series are indicated for use as | |||
| inlays, onlays, veneer, partial | |||
| crowns and crowns. | Once finalized into a suitable | ||
| design, the n!ceTM glass- | |||
| ceramic blocks are indicated | |||
| for use as inlays, onlays, | |||
| veneer, partial crowns and | |||
| crowns. | Equivalent | ||
| Classification Reg | 21 CFR 872.6660 | 21 CFR 872.6660 | Identical |
| FDA Product Code | EIH | EIH | Identical |
| Materials | SiO2, Li2O, K2O, | ||
| P2O5, Al2O3 and other | |||
| oxides | SiO2, Li2O, K2O, | ||
| P2O5, Al2O3 and other oxides | Equivalent | ||
| Crystallization | |||
| State as Supplied | Fully crystallized | Fully crystallized | Equivalent |
| Device Design | Block | Block | Equivalent |
| Size | C12 block(10 x 12 x 15mm) | ||
| C14 block(12 x 14 x 18mm) | |||
| C16 block(17.5 x 16 x | |||
| 18mm) | C14 block(12.4 x14.5 | ||
| x18.0mm) | (Similar)#1 |
- Proposed device and
predicate device are essentially |
| | | | equivalent, but the proposed
device has various size of
models. |
| Shades | Various
Translucency :
High translucency(HT)
Low translucency(LT)
Medium Opacity(MO)
Shade :
LT/ HT : 16 A-D and 4
Bleach
MO : 5 MO0- MO4 | Various
Translucency :
High translucency(HT)
Low translucency(LT)
Shade :
HT/ LT : 6 A-D | Equivalent |
| Principle of
Operation | Fabricating restorations
using CAD/CAM system | Fabricating restorations using
CAD/CAM system | Equivalent |
| Type/Class per
ISO 6872 | Type Ⅱ, Class 3 | Type Ⅱ, Class 2 | (Similar)#2 - Proposed devices and
predicate devices are
essentially equivalent, but the
indication vary depending on
the classification of clinical use
in ISO 6872.
Classification is determined by
mechanical and chemical
properties.
The result of flexural strength
tested according to ISO 6872
standard is 519 MPa, so it
corresponds to Class 3
according to Table 1.
Classification table. |
| Flexural strength | > 300MPa
(meeting the ISO6872
requirements) | > 100MPa
(meeting the ISO6872
requirements) | Equivalent |
| Chemical solubility |