Initial LiSi Block

K153130 · GC America, Inc. · EIH · Sep 13, 2016 · Dental

Device Facts

• Record ID: K153130
• Device Name: Initial LiSi Block
• Applicant: GC America, Inc.
• Product Code: EIH · Dental
• Decision Date: Sep 13, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.6660
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

Initial LiSi Block is a glass ceramic block system mounted on a milling machine-specific mandrel; designed for use with CAD/CAM milling systems to fabricate indirect dental restorations. The device is provided in its final 'as-used' state, eliminating the need for post-milling sintering or crystallization. Clinicians (dentists) use intraoral imaging to capture dental anatomy, design the restoration via CAD software, and mill the block. Post-milling, the restoration is finished, polished, and optionally customized with porcelain stain before cementation. The device serves as a tertiary element (superstructure) on implant abutments or as a standalone crown/bridge/veneer. It benefits patients by providing esthetic, durable, and functional tooth replacements with a streamlined workflow compared to materials requiring furnace firing.

Clinical Evidence

Bench testing only. Biocompatibility evaluated per ISO 10993-1:2009. Physical/chemical performance testing conducted per ISO 6872:2008, including uniformity, freedom from extraneous materials, radioactivity, biaxial flexural strength (>300 MPa), chemical solubility, glass transition temperature, and thermal expansion coefficient. Additional testing included shade, fracture toughness, and bulk density.

Technological Characteristics

CAD/CAM machinable lithium silicate glass ceramic block. Supplied in five translucency levels (HT, MT, LT, MO, HO). Complies with ISO 6872:2008. No sintering/crystallization required. Dimensions vary by block size. Standalone device used with external CAD/CAM milling equipment.

Indications for Use

Indicated for fabrication of dental restorations including veneers, inlays, onlays, crowns, 3-unit bridges (anterior/premolar), and implant superstructures for single-tooth restorations in anterior and posterior regions.

Regulatory Classification

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.

Predicate Devices

• IPS E.MAX CAD / IPS E.MAX ZIRCAD (K051705)

Reference Devices

• MSCB-001 (K152274)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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:

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).

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: | [phone] |
| | Fax: | [phone] |
| | Alternate Contact: | Lori Rietman |
| | Phone: | [phone] |
| | Fax: | [phone] |
| | 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:

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.

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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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.
- న్. Indications for Use:

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).

- 6. 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 5.1<br>Uniformity | Check by visual inspection. | Uniformly dispersed throughout the<br>dental ceramic material. |
| 2 | Freedom from<br>extraneous<br>materials | ISO 6872: 2008 5.2<br>Freedom from<br>extraneous materials | Check by visual inspection. | Free from extraneous materials. |
| 3 | Radioactivity | ISO 6872:2008 7.2<br>Radioactivity of dental<br>ceramic | Mill powder using tungsten carbide<br>milling media. Sieve and obtain 50g of<br>powder with a particle size less than<br>75 μm | Not have more an activity concentration<br>of more than 1.0 Bq ⋅ g-1 or uranium 238<br>(gamma spectroscopy technique) |
| 4 | Flexural<br>strength | ISO 6872: 2008 5.4<br>Physical and chemical<br>properties | Biaxial flexure test<br>Test specimens are placed on the<br>three supporting balls. Load is applied<br>the center of the test piece. Determine<br>the load required to break the<br>specimen. | Greater than 300 MPa |
| 5 | Chemical<br>solubility | ISO 6872: 2008 5.4<br>Physical and chemical<br>properties | Specimens are soaked in acetic acid,<br>4% by volume solution in water at<br>80 °C for 16 hours. | Less than 100µg ⋅ cm-2 |
| 6 | Glass<br>transition<br>temperature | ISO 6872: 2008 5.4<br>Physical and chemical<br>properties | Graphically determine by referring to<br>the expansion curves obtained by<br>dilatometric measurement. | Not deviate by more than 20°C from the<br>value stated by the manufacturer. |
| 7 | Thermal<br>expansion<br>coefficient | ISO 6872: 2008 5.4<br>Physical and chemical<br>properties | Graphically determine by referring to<br>recorded values indicating the<br>expansion in relation to temperature<br>obtained by dilatometric<br>measurement. | Not deviated by more than 0.5 X 10-6 K-1<br>from the value stated by the<br>manufacturer. |

### 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 for<br>use | To fabricate veneers, inlays, onlays, crowns in<br>the anterior and posterior region, 3-unit<br>bridges in the anterior region, 3 unit bridges in<br>the premolar region up to the second<br>premolar as the terminal abutment, implant<br>superstructures for single tooth restorations<br>(anterior and posterior region). | IPS e.max CAD is a CAD/CAM machinable glass<br>ceramic based on lithium disilicate for the<br>preparation of full ceramic crowns, inlays, onlays,<br>and full ceramic 3-unit anterior bridges.<br>IPS e.max ZirCAD consists of machinable zirconia<br>blocks for the preparation of full ceramic crowns,<br>onlays and 3- and 4-unit bridges and inlay bridges<br>(anterior and molar.) | Metal free indirect restorations: full crown, inlays,<br>onlays, laminated veneer. |
| Product<br>description | Initial LiSi Block is a CAD/CAM machineable<br>ceramic block based on lithium silicate for full<br>ceramic restorations of both anterior and<br>posterior. | IPS e.max CAD is a CAD/CAM machineable glass<br>ceramic based on lithium disilicate for the<br>preparation of full ceramic restorations.<br>IPS e.max ZirCAD is a yttrium-stabilized zirconium<br>oxide block. | MSCB is a block system consisting of a porcelain<br>block cemented to a milling machine specific<br>mandrel. This block/mandrel is designed to be<br>milled in a CAD/CAM milling machine that is<br>programmed to fabricate an indirect restoration.<br>After milling, the restoration can be customized<br>by use of porcelain stain. The composition of this<br>product allows for milling without need to fire in a<br>porcelain furnace. |
| Instructions<br>for use | 1. Preparation<br>2. Intraoral imaging, CAD/CAM process<br>3. Finishing and polishing<br>4. Staining<br>5. Preparation for cementation<br>6. Cementation | 1. Preparation<br>2. Intraoral imaging, CAD/CAM process<br>3. Finishing and polishing<br>4. Staining<br>5. Crystallization<br>6. Preparation for cementation<br>7. Cementation | 1. Preparation design<br>2. Milling<br>3. Finishing and polishing<br>4. Cementation with sandblasting technique<br>5. Cementation without sandblasting technique<br>6. 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.