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.

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.

AI/ML Overview

The provided document is a 510(k) summary for the Amber Mill Q Series & Amber Mill Direct Series, which are dental ceramic materials. The document focuses on demonstrating substantial equivalence to a predicate device, not on proving device performance against acceptance criteria for an AI/CADe system or a clinical diagnostic device. Therefore, it does not contain the information requested in your prompt regarding acceptance criteria, study details for a test set, expert involvement, MRMC studies, standalone performance, or training set details for an AI/CADe device.

The document primarily addresses the physical, chemical, and biological properties of the dental ceramic and compares them to an existing ceramic product. The "tests" mentioned are for material properties (e.g., flexural strength, chemical solubility, biocompatibility), typical for materials science, not for diagnostic performance in the context of an AI algorithm.

Here's a breakdown of why I cannot fulfill your request based on the provided text:

No Acceptance Criteria for AI/CADe: The document does not define acceptance criteria such as sensitivity, specificity, AUC, or other metrics common for AI performance evaluation.
No Reported Device Performance for AI/CADe: There are no performance metrics like those for an AI system. The performance reported is for material properties (e.g., flexural strength > 300MPa) for the dental ceramic, not an AI algorithm.
No Test Set/Data Provenance for AI: There is no mention of a test set of images or patient data, nor its size, origin (country), or whether it was retrospective or prospective.
No Experts/Ground Truth for AI: The document does not discuss experts establishing ground truth for diagnostic purposes because it's a material, not a diagnostic AI. Ground truth, in this context, would be material property measurements, not clinical diagnoses.
No Adjudication Method: Adjudication is irrelevant for material property testing.
No MRMC Comparative Effectiveness Study: This type of study is for evaluating human performance with and without AI assistance, which is not applicable here.
No Standalone AI Performance: The device itself is a ceramic material, not a software algorithm, so "standalone performance" doesn't apply in the AI sense.
Type of Ground Truth: The "ground truth" for this device would be direct measurements of its material properties according to ISO standards, not expert consensus or pathology on clinical images.
No Training Set for AI: There's no training set mentioned because the device is not an AI algorithm that learns from data.
No Ground Truth Establishment for Training Set: Again, not applicable as it's not an AI device.

In summary, the provided text describes a medical device clearance for a dental ceramic material (Amber Mill Q Series & Amber Mill Direct Series) and demonstrates its substantial equivalence to an already marketed predicate device based on material properties and intended use. It does not contain information related to the acceptance criteria or study details for an artificial intelligence (AI) or computer-aided detection (CADe) device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

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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

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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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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:

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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 andAmber Mill Direct Series	Straumann n!ce Glass-CeramicBlocks	-
Common Name	Porcelain powder for clinicaluse	Porcelain powder for clinicaluse	-
Manufacturer	HASS CORP.	Institut Straumann AG	-
Indication For Use	Once finalized into a suitabledesign, the Amber Mill QSeries and Amber Mill DirectSeries are indicated for use asinlays, onlays, veneer, partialcrowns and crowns.	Once finalized into a suitabledesign, the n!ceTM glass-ceramic blocks are indicatedfor use as inlays, onlays,veneer, partial crowns andcrowns.	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 otheroxides	SiO2, Li2O, K2O,P2O5, Al2O3 and other oxides	Equivalent
CrystallizationState 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 x18mm)	C14 block(12.4 x14.5x18.0mm)	(Similar)#1* Proposed device andpredicate device are essentially
			equivalent, but the proposeddevice has various size ofmodels.
Shades	VariousTranslucency :High translucency(HT)Low translucency(LT)Medium Opacity(MO)Shade :LT/ HT : 16 A-D and 4BleachMO : 5 MO0- MO4	VariousTranslucency :High translucency(HT)Low translucency(LT)Shade :HT/ LT : 6 A-D	Equivalent
Principle ofOperation	Fabricating restorationsusing CAD/CAM system	Fabricating restorations usingCAD/CAM system	Equivalent
Type/Class perISO 6872	Type Ⅱ, Class 3	Type Ⅱ, Class 2	(Similar)#2* Proposed devices andpredicate devices areessentially equivalent, but theindication vary depending onthe classification of clinical usein ISO 6872.Classification is determined bymechanical and chemicalproperties.The result of flexural strengthtested according to ISO 6872standard is 519 MPa, so itcorresponds to Class 3according to Table 1.Classification table.
Flexural strength	> 300MPa(meeting the ISO6872requirements)	> 100MPa(meeting the ISO6872requirements)	Equivalent
Chemical solubility	< 100 ug / cm $^{2}$(meeting the ISO6872requirements)	< 100 ug / cm $^{2}$(meeting the ISO6872requirements)	Equivalent
Freedom fromExtraneous Material	Shall be free from extraneousmaterials when assessed byvisual inspection ( meetingISO 6872 requirements)	Shall be free from extraneousmaterials when assessed byvisual inspection ( meetingISO 6872 requirements)	Equivalent
Radioactivity	Activityconcentration ofuranium $^{238}$ lessthan 1.0Bq g $^{-1}$(meeting the ISO6872requirements)	Activityconcentration ofuranium $^{238}$ lessthan 1.0Bq g $^{-1}$(meeting the ISO6872requirements)	Identical
Linear of thermalexpansion	11.5±0.5 × 10 $^{-6}$ /°C(meeting the ISO6872requirements)	12.0±0.5 × 10 $^{-6}$ /°C(meeting the ISO6872requirements)	Equivalent
Glass TransitionTemperature	Activityconcentration ofuranium $^{238}$ less	Activityconcentration ofuranium $^{238}$ less	Equivalent
	than 1.0Bq g-1(meeting ISO 6872requirements)	than 1.0Bq g-1(meeting ISO 6872requirements)
Biocompatibility	Non-toxic and biocompatible(Meeting the ISO10993-3, 5, 10 and10993-11Requirements)	Non-toxic and biocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Equivalent

510(k) summary

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Substantial Equivalence Discussion

The subject device has the same intended use and the same principle of operation as the predicate devices. The subject device and the predicate devices might have a slight difference in compositions but all the devices

have SiO2, Li2O, K2O, P2O5, and A12O3 as major components.

Despite this difference, the test results per ISO 6872 shows that the subject device is substantially equivalent to the predicate device 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), and Irritation (ISO 10993-10) to meet the biocompatibility requirements. Based on the test results and the information provided in this submission, we conclude that the subject device is substantially equipment to the predicate devices.

8. Non-Clinical Testing

. 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. ●

9. Conclusion

The subject device and the predicate device have the same intended use and have the same technological characteristics. Based on the similarities and the test results, we conclude that the subject device is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.