To fabricate veneers, inlays, onlays, crowns in the anterior region, 3-unit bridges in the anterior region, 3 unit bridges in the premolar region up to the second premolar as the terminal abutment, implant superstructures for single tooth restorations (anterior and posterior region).

Device Description

Initial LiSi Block is a block system consisting of a glass ceramic block cemented to a milling machine specific mandrel. This block is designed to be milled in a CAD/CAM milling machine that is programmed to fabricate indirect restorations such as veneers, inlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal abutment, and implant superstructures for single-tooth restorations.

Initial LiSi Block is intended to fabricate the tertiary element/exostructure of the implant superstructure, such as a crown. This structure sits on top of an abutment to achieve esthetic and generate compatible occlusal forces. The implant superstructure is classified as a fixed prosthesis.

After milling, the restoration can be customized by use of porcelain stain. The composition and manufacturing process of this product allows for milling without the need to fire (sintering) in a porcelain furnace.

All raw materials are melted at very high temperatures and the melting process prior to distribution eliminates all volatile substances. Final product is provided as complex oxide ceramics.

The device is available in a range of shades, including high, medium, and low translucency, as well as medium and high opacity:

(High Translucency); HT-BLE, HT-E0P, HT-E57, HT-E58, HT-E59, HT-E60, HT-NTL, HT-AMB, HT HT-B00, HT-B0, HT-A0, HT-A1, HT-A2, HT-A3, HT-A3, HT-A4, HT-B1, HT-B2, HT-B3, HT-B4, HT-C1, HT-C2, HT-C3, HT-C4, HT-D2, HT-D3, HT-D3, HT-D4 (27)
MT (Medium Translucency): MT-B00, MT-A0, MT-A0, MT-A2, MT-A3, MT-A3.5, MT-A4, MT-B1, MT-B2, MT-B4, MT-C1, MT-C2, MT-C2, MT-C3, MT-C4, MT-D2, MT-D3, MT-D4, MT-0, MT-A, MT-B, MT-C, MT-D (24)
LT (Low Translucency): LT-B00, LT-A0, LT-A1, LT-A2, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-C1, LT-C1, LT-C2, LT-C3, LT-C4, LT-D2, LT-D3, LT-D4, LT-0, LT-A, LT-B, LT-C, LT-D (24)
MO (Medium Opacity): MO-0, MO-1, MO-2, MO-3, MO-4 (5)
HO (High Opacity): HO-0, HO-1, HO-2, HO-3, HO-4 (5)
Shelf Life: 10 years from the date of manufacture -
Storage: Recommended for optimal performance, store at room temperature (4-25°C/39.2-77.0°F) away from direct sunlight and high humidity.

AI/ML Overview

The provided document describes the "Initial LiSi Block," a CAD/CAM machineable glass ceramic block for dental restorations. The study described focuses on non-clinical performance testing to demonstrate substantial equivalence to predicate devices, rather than a clinical study evaluating device performance in humans.

Here's a breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The device performance is reported against the requirements of ISO 6872:2008 - Dentistry - Ceramic Materials, and additional physical and chemical properties.

Property	Acceptance Criteria (from ISO 6872:2008 or manufacturer's requirements)	Reported Device Performance (Implied by "complies with all the requirements" or "acceptable")
Uniformity	Uniformly dispersed throughout the dental ceramic material.	Complies
Freedom from extraneous materials	Free from extraneous materials.	Complies
Radioactivity	Not more than 1.0 Bq ⋅ g⁻¹ of uranium 238 (gamma spectroscopy technique)	Complies
Flexural strength (Biaxial flexure test)	Greater than 300 MPa	Complies (and "higher flexural strength" than reference predicate MSCB)
Chemical solubility	Less than 100µg ⋅ cm⁻²	Complies
Glass transition temperature	Not deviate by more than 20°C from the value stated by the manufacturer.	Complies
Thermal expansion coefficient	Not deviated by more than 0.5 X 10⁻⁶ K⁻¹ from the value stated by the manufacturer.	Complies
Shade	Equivalent to the standard product.	Complies
Fracture toughness	No specific requirement (calculated using Vickers-hardness).	Reported (value not specified, but calculation was performed).
Bulk density	No specific requirement (calculated).	Reported (value not specified, but calculation was performed).
Biocompatibility	Acceptable according to ISO 10993-1:2009.	Acceptable

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of human data or a model evaluation with a defined sample size. The testing described is primarily non-clinical, involving material property evaluation.

Sample Size: Not applicable in the context of a "test set" for performance evaluation from patient data. The tests are performed on material samples, but specific sample numbers for each test (e.g., number of blocks for flexural strength) are not provided.
Data Provenance: The data provenance is from laboratory testing of the device material. It is retrospective in the sense that the material is manufactured and then tested. There are no mentions of country of origin for the data other than the manufacturing company being GC America Inc. (Illinois, USA) and GC Corporation (presumably Japan, given the company names in the predicate table).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not applicable as the described study is a non-clinical evaluation of material properties, not a study involving expert assessment of diagnostic or clinical outcomes. Ground truth for material properties is established through adherence to international standards and validated laboratory test methods.

4. Adjudication method for the test set

This information is not applicable as there is no test set requiring adjudication by experts or human readers.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This submission is for a dental material (ceramic block), not an AI-powered diagnostic or assistive device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, a standalone algorithm-only performance study was not done. This device is a physical material for dental restorations.

7. The type of ground truth used

The ground truth used for this device's evaluation is primarily based on:

International Standards: Specifically, ISO 6872:2008 (Dentistry - Ceramic Materials) for physical and chemical properties, and ISO 10993-1:2009 for biocompatibility. These standards define the acceptable range or threshold for material characteristics.
Manufacturer Specifications: For properties like glass transition temperature and thermal expansion coefficient where the requirement is "Not deviate by more than [X] from the value stated by the manufacturer."
Visual Inspection: For properties such as uniformity, freedom from extraneous materials, and shade.

8. The sample size for the training set

This information is not applicable. There is no "training set" in the context of machine learning or AI as this is a physical medical device.

9. How the ground truth for the training set was established

This information is not applicable. There is no "training set" for this type of device submission.

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" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing to the right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 13, 2016

GC America Inc. Dr. Mark Heiss Director, Academic & Regulatory Affairs 3737 W. 127th Street Alsip, Illinois 60803

Re: K153130

Trade/Device Name: Initial Lisi Block Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain Powder for Clinical Use Regulatory Class: Class II Product Code: EIH Dated: June 14, 2016 Received: June 15, 2016

Dear Dr. Heiss:

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 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.

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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,

Image /page/1/Picture/7 description: The image contains a signature that reads "Susan Runno DDS, MA". The signature is written in cursive with a black ink. The letters are connected and flow smoothly together.

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

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Indications for Use Statement

510(k) Number : K153130

Device Name: Initial LiSi Block

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

Over the counter Use

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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510(k) Summary

1.	Submitter Information:
	GC AMERICA INC.
	3737 W. 127th Street
	Alsip, IL 60803
	Contact Person:	Mark Heiss, D.D.S.
	Phone:	(708) 926-3090
	Fax:	(708) 926-9100
	Alternate Contact:	Lori Rietman
	Phone:	(708) 926-3092
	Fax:	(708) 926-9100
	Date Prepared:	June 14, 2016
2.	Device Name:	Initial LiSi Block
	Proprietary Name:	Powder, Porcelain
	Classification Name:	Class II, 872.6660
	Device Classification:
	Product Code:	EIH

3. Predicate Device:

Product	Applicant	510(k) No.	Code No.	Predicate
IPS E.MAX CAD / IPS E.MAX ZIRCAD	IVOCLAR VIVADENT, INC	K051705	EIH	Primary
MSCB-001	GC CORPORATION	K152274	EIH	Reference

NOTE: In order to distinguish between device name and product name in this 510(k), device names are expressed in the following manner:

Product (Device name)	510(k) No.	Product name
IPS E.MAX CAD / IPS E.MAX ZIRCAD	K051705	IPS e.max CAD
MSCB-001	K152274	MSCB

4. Description of Device:

Image /page/3/Figure/9 description: The image shows two diagrams of dental implants. The diagram on the left shows a single tooth implant with measurements of 1.0, 1.2, and 1.5. The diagram on the right shows a molar implant with measurements of 1.0 and 1.5. The image also includes labels for the primary element (implant), secondary element (abutment), and tertiary element (superstructure).

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All raw materials are melted at very high temperatures and the melting process prior to distribution eliminates all volatile substances. Final product is provided as complex oxide ceramics.

The device is available in a range of shades, including high, medium, and low translucency, as well as medium and high opacity:

(High Translucency); HT-BLE, HT-E0P, HT-E57, HT-E58, HT-E59, HT-E60, HT-NTL, HT-AMB, HT HT-B00, HT-B0, HT-A0, HT-A1, HT-A2, HT-A3, HT-A3, HT-A4, HT-B1, HT-B2, HT-B3, HT-B4, HT-C1, HT-C2, HT-C3, HT-C4, HT-D2, HT-D3, HT-D3, HT-D4 (27)
MT (Medium Translucency): MT-B00, MT-A0, MT-A0, MT-A2, MT-A3, MT-A3.5, MT-A4, MT-B1, MT-B2, MT-B4, MT-C1, MT-C2, MT-C2, MT-C3, MT-C4, MT-D2, MT-D3, MT-D4, MT-0, MT-A, MT-B, MT-C, MT-D (24)
LT (Low Translucency): LT-B00, LT-A0, LT-A1, LT-A2, LT-A3, LT-A3.5, LT-A4, LT-B1, LT-B2, LT-B3, LT-C1, LT-C1, LT-C2, LT-C3, LT-C4, LT-D2, LT-D3, LT-D4, LT-0, LT-A, LT-B, LT-C, LT-D (24)
MO (Medium Opacity): MO-0, MO-1, MO-2, MO-3, MO-4 (5)
HO (High Opacity): HO-0, HO-1, HO-2, HO-3, HO-4 (5)
- Shelf Life: 10 years from the date of manufacture -
- Storage: Recommended for optimal performance, store at room temperature । (4-25°C/39.2-77.0°F) away from direct sunlight and high humidity.
న్. Indications for Use:

1. Non Clinical Performance Testing:
  A biocompatibility assessment was completed according to ISO 10993-1:2009. Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process.

Initial LiSi Block is a CAD/CAM machineable glass ceramic block for the preparation of full ceramic restoration and does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours.

In conclusion, biocompatibility of Initial LiSi Block is acceptable device from the biological evaluation result.

It is confirmed that the device conforms to the required specifications of ISO 6872:2008 - Dentistry -Ceramic Materials and is suitable for its intended use. Performance testing includes:

. Uniformity
Freedom from extraneous materials
Radioactivity
. Flexural strength (Biaxial flexure test)
Chemical solubility
Glass transition temperature ●
. Thermal expansion coefficient

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Additional physical and chemical property testing includes:

Shade
Fracture toughness
Bulk density

	Property	Standards	Test methods	Requirements
1	Uniformity	ISO 6872: 2008 5.1Uniformity	Check by visual inspection.	Uniformly dispersed throughout thedental ceramic material.
2	Freedom fromextraneousmaterials	ISO 6872: 2008 5.2Freedom fromextraneous materials	Check by visual inspection.	Free from extraneous materials.
3	Radioactivity	ISO 6872:2008 7.2Radioactivity of dentalceramic	Mill powder using tungsten carbidemilling media. Sieve and obtain 50g ofpowder with a particle size less than75 μm	Not have more an activity concentrationof more than 1.0 Bq ⋅ g-1 or uranium 238(gamma spectroscopy technique)
4	Flexuralstrength	ISO 6872: 2008 5.4Physical and chemicalproperties	Biaxial flexure testTest specimens are placed on thethree supporting balls. Load is appliedthe center of the test piece. Determinethe load required to break thespecimen.	Greater than 300 MPa
5	Chemicalsolubility	ISO 6872: 2008 5.4Physical and chemicalproperties	Specimens are soaked in acetic acid,4% by volume solution in water at80 °C for 16 hours.	Less than 100µg ⋅ cm-2
6	Glasstransitiontemperature	ISO 6872: 2008 5.4Physical and chemicalproperties	Graphically determine by referring tothe expansion curves obtained bydilatometric measurement.	Not deviate by more than 20°C from thevalue stated by the manufacturer.
7	Thermalexpansioncoefficient	ISO 6872: 2008 5.4Physical and chemicalproperties	Graphically determine by referring torecorded values indicating theexpansion in relation to temperatureobtained by dilatometricmeasurement.	Not deviated by more than 0.5 X 10-6 K-1from the value stated by themanufacturer.

Table 1 Physical and chemical properties required by ISO 6872:2008

Table 2 Additional physical and chemical properties

	Property	Test methods	Requirements
1	Shade	Check by visual inspection.	Equivalent to the standard product.
2	Fracture toughness	Calculate by using Vickers-hardness.	No requirements
3	Bulk density	Calculate.	No requirements

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7. Technological characteristics:

Initial LiSi Block is a CAD/CAM machineable glass ceramic block the preparation of full ceramic restoration. Its indications include fabrication of occlusal veneers, veneers, inlays, onlays, crowns in the anterior and posterior region, 3-unit bridges in the anterior region, 3-unit bridges in the premolar region up to the second premolar as the terminal, crown or splinted crown on top of an implant abutment and 3-unit bridge up to the second premolar placed on top of an implant abutment.

Initial LiSi Blocks are supplied in five levels of translucency (HT. MT. LT. MO. HO). Instructions for use include preparation, intraoral imaging, CAD/CAM process, polishing, staining, preparation for cementation, and cementation.

IPS e.max CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of veneers, inlays, onlays, partial crowsn, corwns in the anterior region, implant superstructures for single-tooth restorations (anterior region), and primary telescope crown. IPS e.max ZirCAD consists of machinable zirconia blocks for the preparation of crown frameworks for anterior and posterior restorations, 3- to 12-unit bridge frameworks for the anterior and posterior regions, inlay bridge frameworks, primary telescope crowns, implant superstructures (single-tooth and bridge frameworks), and interlocked crown frameworks.

IPS e.max CAD blocks are supplied in four levels of translucency (HT, MT, LT, MO) as well as an impulse version. The monochromatic blocks are available in eight sizes. IPS e.max ZirCAD are supplied in nine block sizes and three shades (MO 0, MO 1, MO 2). Instructions for use include preparation, intraoral imaging, CAD/CAM process, polishing, crystallization, preparation for cementation, and cementation.

MSCB is a block system consisting of a porcelain block cemented to a milling machine specific mandrel. This block/mandrel is designed to be milled in a CAD/CAM milling machine that is programmed to fabricate an indirect restoration. After milling, the restoration can be customized by use of porcelain stain. The composition of this product allows for milling without need to fire in a porcelain furnace. Its indications include fabrication of Metal free indirect restorations: full crown, inlays, onlays, and laminated veneer.

MSCB is supplied in 5 *Vita shades in two translucencies (HT and LT) in three sizes (12/14/14L). Instructions for use include preparation design, milling, finishing and polishing, cementation with sandblasting technique, cementation without sandblasting technique, and characterization. * Vita® is a registered trademark of Vita Zahnfabrik, Bad Säckingen, Germany.

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	Applicant device	Primary Predicate Device	Reference Predicate Device
Trade name	Initial LiSi Block	IPS e.max CAD	MSCB-001
Product	CAD/CAM machineable ceramic block.	CAD/CAM machineable ceramic block.	CAD/CAM restorative
category
Company	GC CORPORATION	IVOCLAR VIVADENT, INC	GC CORPORATION
510(k) No.		K051705	K152274
Indications foruse	To fabricate veneers, inlays, onlays, crowns inthe anterior and posterior region, 3-unitbridges in the anterior region, 3 unit bridges inthe premolar region up to the secondpremolar as the terminal abutment, implantsuperstructures for single tooth restorations(anterior and posterior region).	IPS e.max CAD is a CAD/CAM machinable glassceramic based on lithium disilicate for thepreparation of full ceramic crowns, inlays, onlays,and full ceramic 3-unit anterior bridges.IPS e.max ZirCAD consists of machinable zirconiablocks for the preparation of full ceramic crowns,onlays and 3- and 4-unit bridges and inlay bridges(anterior and molar.)	Metal free indirect restorations: full crown, inlays,onlays, laminated veneer.
Productdescription	Initial LiSi Block is a CAD/CAM machineableceramic block based on lithium silicate for fullceramic restorations of both anterior andposterior.	IPS e.max CAD is a CAD/CAM machineable glassceramic based on lithium disilicate for thepreparation of full ceramic restorations.IPS e.max ZirCAD is a yttrium-stabilized zirconiumoxide block.	MSCB is a block system consisting of a porcelainblock cemented to a milling machine specificmandrel. This block/mandrel is designed to bemilled in a CAD/CAM milling machine that isprogrammed to fabricate an indirect restoration.After milling, the restoration can be customizedby use of porcelain stain. The composition of thisproduct allows for milling without need to fire in aporcelain furnace.
Instructionsfor use	1. Preparation2. Intraoral imaging, CAD/CAM process3. Finishing and polishing4. Staining5. Preparation for cementation6. Cementation	1. Preparation2. Intraoral imaging, CAD/CAM process3. Finishing and polishing4. Staining5. Crystallization6. Preparation for cementation7. Cementation	1. Preparation design2. Milling3. Finishing and polishing4. Cementation with sandblasting technique5. Cementation without sandblasting technique6. Characterization

Table 5.3 Comparison of applicant device to predicate devices

The applicant device and primary predicate device, IPS e.max CAD, are the same in function and intended use, and similar in composition. There is no difference in indications and descriptions for use, the predicate device requires crystallization step in process while applicant device is provided in its "as-used" state.

The applicant and reference predicate device in composition as well as description such that both are a block system intended to be designed and milled in a CAD/CAM milling machine with no requrement to fire in a porcelain furnace as they are provided in its "as-used" state.

The differences in indications for use are in the different types of restorations fabricated. This does not affect the equivalence to the predicate devices.

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8. Substantial equivalence:

The applicant device complies with all the requirements of ISO 6872: 2008 (Dentistry - Ceramic materials) (Table 5.1) as well as additional requirements presented in Table 5.2. Initial LiSi Block and primary predicate IPS e.max CAD are similar in composition that both are silica based glass ceramics. The applicant device and primary predicate device IPS e.max CAD are the same in function and intended use. Only difference relates to instructions for use: the predicate device requires crystallization step in process while applicant device is provided in its "as-used" state. The differences do not affect the equivalency of the applicant device to the primary predicate device.

All of the components of the applicant device have already been used in the primary predicate device. The substantial equivalence of the applicant device was determined by means of comparing to ISO 6872:2008 standards as well as the predicate devices.

9. Differences:

The following technological differences exist between the applicant device and the primary predicate device:

Slight difference in formulation ●
Difference in translucency shades and block sizes available
Unnecessary crystallization process

However, there is no difference in instructions, indications or description except for crystallization. All of the components of the applicant device have already been used in the primary predicate device.

Compared to reference predicate MSCB. Initial LiSi Block has a higher flexural strength in accordance with ISO 6872:2008 - Dentistry - Ceramic Materials.

Conclusion: 10.

Based on chemical composition and non-clinical testing, we find the applicant device 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.