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.

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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Title	Test Standard	Acceptance Criteria (Requirement/Criteria)	Reported Device Performance (Test Result)
Visual Inspection	N/A	There shall be no extraneous materials, distributing at use when assessed by visual inspection.	There were no extraneous materials, distributing at use when assessed by visual inspection. (PASS)
Size Test Report	N/A	The size tolerance should be within +/- 2mm.	PASS
Package Test Report	N/A	There shall be no breakage, no crack, no pollution of foreign body and no problem of use in product.	There was no breakage, no crack, no pollution of foreign body and no problem of use in product. (PASS)
Uniformity Test Report	ISO 6872	Colorants shall be dispersed uniformly on the block.	Colorants were dispersed uniformly on the block. (PASS)
Foreign Body Test Report	ISO 6872	It shall be free from extraneous materials.	They were free from extraneous materials. (PASS)
Chemical Solubility Test Report	ISO 6872	less than 100 µg/cm²	PASS
Flexural Strength Test Report	ISO 6872	Over 300 MPa	PASS
Radioactivity Test Report	ISO 6872	U238: Less than 1.0 Bq/g	PASS
Linear Thermal Expansion Test Report	ISO 6872	10.0 +/- 0.5 10^-6 K^-1	PASS
Glass Transition Temperature Test Report	ISO 6872	550 +/- 20 °C	PASS
Genotoxicity	ISO 10993-3	< 2.0	PASS
Cytotoxicity test	ISO 10993-5	≥ 70%	PASS
Irritation test	ISO 10993-10	No mutation	PASS
Sensitization test	ISO 10993-10	< 1.6	PASS
Systemic toxicity (oral) test	ISO 10993-11	No abnormality and death	PASS

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly state the sample sizes used for each of the non-clinical tests or the data provenance (e.g., country of origin, retrospective/prospective). The tests listed are primarily bench tests on the material itself, not clinical studies involving human subjects or real-world data collection. The tests seem to be conducted in a laboratory setting as part of the material characterization.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. The tests performed are objective, quantitative material property tests according to international standards (ISO). Ground truth in this context is established by the specified standards and measured values, not by expert consensus or interpretation of images/cases.

4. Adjudication Method for the Test Set:

Not applicable. As noted above, the tests are objective material property measurements against defined standards. There is no need for an adjudication method for interpreting results.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not done. This device is a dental material, not an AI-assisted diagnostic or imaging device used by human readers for interpretation.

6. Standalone (Algorithm Only) Performance:

Not applicable. This device is a dental material. The performance tests are specific to the physical, chemical, and biological properties of the material itself.

7. Type of Ground Truth Used:

The ground truth used for these tests is based on the objective requirements and criteria specified in international standards (ISO 6872, ISO 10993-3, ISO 10993-5, ISO 10993-10, ISO 10993-11) and internal bench testing requirements. This is essentially definitive physical/chemical/biological measurement standards.

8. Sample Size for the Training Set:

Not applicable. This is a material, not a machine learning or AI device that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable. There is no training set for this device.

Summary

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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

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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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

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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:

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 and4 Bleach W shades
Odor	Odorless
Flexural strength	> 300MPa
Chemical solubility	< 100 ug / cm²
Glass TransitionTemperature (Tg)	553 °C

7. Technological Characteristics Summary:

8. Intended 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.

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9. 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 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 Title	Test Standard	Requirement/Criteria	Test Result
Visual InspectionReport		There shall be no extraneousmaterials, distributing at usewhen assessed by visualinspection.	There were no extraneousmaterials, distributing at usewhen assessed by visualinspection.
Size Test Report		The size tolerance should bewithin +/- 2mm	PASS
Package Test Report		There shall be no breakage, nocrack, no pollution of foreignbody and no problem of use inproduct.	There was no breakage, nocrack, no pollution of foreignbody and no problem of use inproduct.
Uniformity Test Report	ISO 6872	Colorants shall be disperseduniformly on the block.	Colorants were disperseduniformly on the block.
Foreign Body TestReport	ISO 6872	It shall be free fromextraneous materials.	They were free fromextraneous materials.
Chemical SolubilityTest Report	ISO 6872	less than 100 µg/cm²	PASS
Flexural Strength TestReport	ISO 6872	Over 300 MPa	PASS
Radioactivity TestReport	ISO 6872	U238: Less than 1.0 Bq/g	PASS
Linear ThermalExpansion Test Report	ISO 6872	10.0+/- 0.5 10-6K-1	PASS

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Glass TransitionTemperature TestReport	ISO 6872	550+/- 20 °C	PASS
Genotoxicity	ISO 10993-3	< 2.0	PASS
Cytotoxicity test	ISO 10993-5	≥ 70%	PASS
Irritation test	ISO 10993-10	No mutation	PASS
Sensitization test	ISO 10993-10	< 1.6	PASS
Systemic toxicity(oral)test	ISO 10993-11	No abnormality and death	PASS

10. Substantial Equivalence

Amber Mill Series and Amber Press Series are substantially equivalent to the Obsidian™ Milling Blocks (K141788) and Obsidian™ Press (K141887). Two predicate devices are chosen for showing substantial equivalence to the predicate devices in the market in terms of milling methods employed for the materials which are CAD/CAM and pressing methods.

The following comparison table is presented to demonstrate substantial equivalence.

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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 Al2O3 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.

11. Conclusion:

Based on the testing results, HASS CORP. concludes that the Amber Mill Series and Amber Press Series are substantially equivalent to the predicate devices.

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.

	Proposed Device	Primary PredicateDevice	Reference PredicateDevice	SubstantialEquivalence
510(k) Number	K160102	K141788	K141887	-
Manufacturer	HASS CORP.	Prismatik Dentalcraft,Inc.	Prismatik Dentalcraft,Inc.	-
Device Name	Amber Mill SeriesAmber Press Series	Obsidian™ MillingBlocks	Obsidian™ Press(All-Ceramic and POM)	-
Common Name	Porcelain powder forclinical use	Porcelain powder forclinical use	Porcelain powder forclinical use	Same
CFR Section	21 CFR 872.6660	21 CFR 872.6660	21 CFR 872.6660	Same
Product Code	EIH	EIH	EIH	Same
Type and classaccording to ISO6872	Monolithic CeramicClass 3	Monolithic CeramicClass 3	Monolithic CeramicClass 3	Same
Indication ForUse	Amber Mill Series areindicated for fabricatingglass ceramicrestorations such assingle-unit anterior andposterior crowns,veneers, inlays/onlays,and anterior 3-unitbridges usingCAD/CAM System.Amber Press Series areindicated for fabricatingglass ceramicrestorations such assingle-unit anterior andposterior crowns,veneers, inlays/onlays,and anterior 3-unitbridges using hot presstechnique.	The Obsidian™ MillingBlocks is used tofabricate ceramic dentalprostheses in the natureof crowns and bridgesfor posterior and anteriorapplications usingCAD/CAM methods.	The Obsidian™ Pressceramic is used tofabricate Press OverMetal dental prosthesesinthe nature of crowns andbridges as well asmonolithic dentalprostheses in the natureof crowns, partialcrowns, veneers, inlays,and onlays for posteriorand anterior applications,as well as 3-unit anteriorbridges (including pre-molar region as terminalabutment) usingpressing methods.	Same
Materials	SiO2, Li2O, K2O,P2O5, Al2O3 andother oxides	SiO2, Li2O, K2O,P2O5, Al2O3 and otheroxides	SiO2, Li2O, K2O,P2O5, Al2O3 and otheroxides	Similar**The subject device andthe predicate devicesmight have a slightdifference incompositions but all thedevices have SiO2,Li2O, K2O, P2O5, andAl2O3 as majorcomponents.Despite this difference,the test results per ISO6872 shows that thesubject device issubstantially equivalentto the predicate device inphysical and chemicalproperties and meets thenecessary requirements.
Main chemicalcompositions(in %)	Silicon dioxide(SiO2)71.45 ~ 78.07%	Silicon dioxide(SiO2)(% not known)	Silicon dioxide(SiO2)(% not known)	Similar
Summary of sizesand shapes	Form of Blocks :(12 × 5 × 15mm ~15.2 × 15.2 × 40mm)Form of Ingots :(Ø12.7×7mm~Ø12.7×20mm)	Form of Blocks:(12 × 5 × 15 mm ~15.2 × 15.2 × 40mm)	Form of Ingots :(Ø12.7×7mm~Ø12.7×20mm)	Similar
Shades	Various(High, Lowtranslucencies andMedium Opacity): 16A-D and 4 Bleach W	Various(A1, A2, A3, A3.5,B1, B2, B3, B4,C1, C2, C3, C4, BL1and BL4)	Various(A1, A2, A3, A3.5,B1, B2, B3, B4,C1, C2, C3, C4, BL1 andBL4)	Similar**The subject device andthe predicate devicesmight have a slight
	shades			difference in shades.Despite this difference,the test results per ISO6872 and 10993standards show that thesubject device issubstantially equivalentto the predicate device inphysical/chemicalproperties andbiocompatibility, andmeet the necessaryrequirements.
Principle ofOperation	Fabricatingrestorations using hotpress technique orCAD/CAM system	Fabricating restorationsusing CAD/CAMsystem	Fabricating restorationsusing hot press technique	Same
Performance testsperformed	• ISO 6872 -Uniformity, ForeignBody, ChemicalSolubility, FlexuralStrength,Radioactivity, LinearThermal Expansion,Glass TransitionTemperature tests• ISO 10993-3 -Genotoxicity• ISO 10993-5 -Cytotoxicity• ISO 10993-10 -Sensitization &Irritation• ISO 10993-11 -SystemicToxicity(oral)• Other bench testing- Visual Inspection,Size, Package tests	• ISO 6872 – ForeignBody, ChemicalSolubility, FlexuralStrength,Radioactivity, LinearThermal Expansion• ISO 10993-5 -Cytotoxicity• ISO 10993-10 -Sensitization &Irritation	• ISO 6872 - ForeignBody, ChemicalSolubility, FlexuralStrength, Radioactivity,Linear ThermalExpansion• ISO 10993-5 -Cytotoxicity• ISO 10993-10 -Sensitization &Irritation	Similar** More performancetests were done on thesubject devices.
Flexural strength	> 300MPa(meeting the ISO6872requirements)	> 300MPa(meeting the ISO6872requirements)	> 300MPa(meeting the ISO6872requirements)	Similar** All devices meet ISO6872 requirements.
Chemicalsolubility	< 100 ug / cm2(meeting the ISO6872requirements)	< 100 ug / cm2(meeting the ISO6872requirements)	< 100 ug / cm2(meeting the ISO6872requirements)	Similar** All devices meet ISO6872 requirements.
Freedom fromExtraneousMaterial	Shall be free fromextraneous materialswhen assessed by visualinspection ( meetingISO 6872 requirements)	Shall be free fromextraneous materialswhen assessed by visualinspection ( meeting ISO6872 requirements)	Shall be free fromextraneous materialswhen assessed by visualinspection ( meeting ISO6872 requirements)	Similar** All devices meet ISO6872 requirements.
Radioactivity	Activityconcentration ofuranium238 lessthan 1.0Bq g-1	Activityconcentration ofuranium238 lessthan 1.0Bq g-1	Activityconcentration ofuranium238 lessthan 1.0Bq g-1	Similar** All devices meet ISO6872 requirements.
	(meeting the ISO6872requirements)	(meeting the ISO6872requirements)	(meeting the ISO6872requirements)
Linear of thermalexpansion	$10.0\pm0.5 \times 10^{-6}/\degree C$(meeting the ISO6872requirements)	$12.0\pm0.5 \times 10^{-6}/\degree C$(meeting the ISO6872requirements)	$12.0\pm0.5 \times 10^{-6}/\degree C$(meeting the ISO6872requirements)	Similar** All devices meet ISO6872 requirements.
Glass TransitionTemperature	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Activityconcentration ofuranium238 lessthan 1.0Bq g-1(meeting ISO 6872requirements)	Similar** All devices meet ISO6872 requirements.
Biocompatibility	Non-toxic andbiocompatible(Meeting the ISO10993-3, 5, 10 and10993-11Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Non-toxic andbiocompatible(Meeting the ISO10993-5 and10993-10Requirements)	Similar** All devices meet ISO10993 requirements.
Shelf-life	Semi-permanent	Semi-permanent	Semi-permanent	Same
Labeling	Package labeling andInstructions for Use	Package labeling andInstructions for Use	Package labeling andInstructions for Use	Same