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.

MSCB-001 system is a feldspathic (glass) porcelain system based on partially crystalline but mostly vitreous materials derived from phyllosilicates such as potash or sodafeldspar, several commercially available fluxes, and various refractive oxides for mechanical enhancement.

AI/ML Overview

This document describes the performance testing for the MSCB-001 device, a porcelain block system used for indirect dental restorations, to demonstrate its substantial equivalence to a predicate device and conformance to ISO 6872:2008.

1. Table of Acceptance Criteria and Reported Device Performance

Property / Unit	Standards	Requirements	Reported Device Performance (MSCB-001)	Predicate Device Performance (VITABLOCS FOR CEREC MK2)
Chemical solubility	ISO 6872: 2008	Less than 100 µg/cm³	Average: 31 µg/cm³ (LT A2), 35 µg/cm³ (HT A2)	Average: 31 µg/cm³
Flexural strength	ISO 6872: 2008	Greater than 100 MPa	Average: 210 MPa (LT A2), 214 MPa (HT A2)	Average: 145 MPa
Linear thermal expansion	ISO 6872: 2008	TG(°C) +/- 10	Average: 470°C (LT A2), 469°C (HT A2)	Average: 785°C
Radioactivity	ISO 6872: 2008	Radioactivity A ≤ 1.0 By/g an 238U	Conformed	Conformed

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

The document does not explicitly state the total sample size for the test set for each property. However, for Chemical Solubility, Flexural Strength, and Linear Thermal Expansion, three individual measurements are listed for both the MSCB-001 (split into LT A2 and HT A2 translucencies) and the predicate device. This suggests a minimum of 3 samples per translucency/device per test, totaling at least 18 individual tests across the two MSCB-001 variations and the predicate for these properties.

The data provenance is retrospective, as the testing was conducted on samples of the device and compared to a legally marketed predicate device. The country of origin of the data is not specified.

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

This study is a bench performance test comparing physical and chemical properties of a dental material to a recognized international standard (ISO 6872:2008) and a predicate device. Therefore, it does not involve human readers or experts establishing ground truth in the context of clinical interpretation or diagnosis. The "ground truth" for the test set is defined by the objective measurements according to the specified ISO standard.

4. Adjudication Method for the Test Set

Not applicable. As a bench performance test, there is no adjudication process involving human experts to determine a "ground truth" outcome. Results are quantitative measurements.

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

No. This is a bench performance study of a dental material, not a clinical study involving human readers or cases. Therefore, an MRMC comparative effectiveness study was not performed, and there is no effect size reported for human readers improving with or without AI assistance.

6. Standalone Performance (Algorithm Only Without Human-in-the-Loop Performance)

Yes, in a sense, this is a "standalone" assessment of the device's physical and chemical properties. The performance metrics (chemical solubility, flexural strength, linear thermal expansion, and radioactivity) are inherent to the material itself and are measured objectively, without human intervention in the result determination beyond operating the testing equipment. This is not an "algorithm" in the typical sense of AI, but the device's performance is evaluated independently.

7. Type of Ground Truth Used

The ground truth used is based on objective measurements against established international standards (ISO 6872:2008) for dental ceramics and comparison to the properties of a legally marketed predicate device.

8. Sample Size for the Training Set

Not applicable. There is no mention of a "training set" in this document, as this is a bench performance test, not a machine learning study.

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

Not applicable, as no training set was used.

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 emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black against a white background.

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

March 25, 2016

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

Re: K152274

Trade/Device Name: MSCB-001 Regulation Number: 21 CFR 872.6660 Regulation Name: Porcelain powder for clinical use Regulatory Class: II Product Code: EIH Dated: February 22, 2016 Received: February 24, 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.

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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 device-related 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.

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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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,

Tina Kiang -

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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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known): K152274

Device Name: MSCB-001

Indications for Use:

Metal free indirect restorations: full crown, inlays, onlays, laminated veneer

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

Page 4.1 of 4.1

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Image /page/3/Picture/1 description: The image shows the letters 'GC' in a stylized font. The letters are in a dark teal color and are set against a white background. There are two apostrophe-like marks, one on either side of the letters. The letters are bold and slightly slanted, giving them a dynamic appearance.

GC AMERICA INC. 3737 WEST 127TH STREET ALSIP, ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103

1. Submitter:

GC AMERICA INC.
3737 W. 127th Street
Alsip, IL 60803
Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Alternate Contact:	Lori Rietman
Phone:	(708)-926-3092
Fax:	(708) 926-9100
Date Prepared:	August 7, 2015

1. Device Name:

Proprietary Name:	MSCB-001
Classification Name:	Porcelain Powder for Clinical Use
Device Classification:	Class II, 872.6660
Product Code:	EIH

1. Predicate Devices:

Company	Device	510(k) No.	Date Cleared
Vita Zahnfarbrik	VITABLOCS FOR CEREC MARK II	K022408	7/24/2002

Description of Device: 4.
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.

1. Indications for Use:

Metal free indirect restorations: full crown, inlays, onlays, and laminated veneer

Package 6.

1. 3 sizes: 12/ 14/ 14L
1. 5 blocks in one package
1. Available CAD/CAM system: Aadva/ CEREC /E4D
1. Shades

5 Vita* shades available in two translucencies:

High Translucency (HT): A1 HT, A2 HT, A3 HT, A3.5 HT, B1 HT
Low Translucency (LT): A1 LT, A2 LT, A3 LT, A3.5 LT, B1 LT

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One bleach shade (BL)
Low Translucency (LT): A1 LT, A2 LT, A3 LT, A3.5 LT, B1 LT
One bleach shade (BL)

Vita® is a registered trademark of Vita Zahnfabrik, Bad Säckingen, Germany,

8. Shelf Life:

10 years from date of manufacture

9. Biocompatibility

According to ISO 10993-1: 2009, the following is stated:

*Sec 4.1 "Evaluation may include both a study of relevant preclinical experience and actual testing. Such an evaluation might result in the conclusion that no testing is needed if the material has a demonstrable safe history of use in a specified role and physical form that is equivalent to that of the device under design."

*Sec 6.1 "Material characterization: "If the combination of all materials, chemicals and processes has an established history of safe use in the intended application, then further characterization and biological evaluation might not be necessary."

All components in MSCB-001 have been used in predicate product, such as VITABLOCS FOR CEREC. Based on above, MSCB was considered to have an acceptable level of biocompatibility

All devices come in contact with the same body tissues (tooth - enamel, dentin) for more than 24 hours.

10. Performance Testing - Bench:

It is confirmed that the device conforms to the required specifications of ISO 6872:2008 and is suitable for its intended use.

Performance testing includes:

. Chemical solubility
. Flexural strength
Linear thermal expansion .
o Radioactivity

Technological characteristics: 11.

All the components of the applicant device, MSCB-001, have already been used in the predicate device (VITABLOCS FOR CEREC MARK II).

1. Substantial equivalence:
  The new and predicate device (VITABLOCS FOR CEREC MARK II) are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

The substantial equivalence was viewed looking at comparison to standards as well as the predicate device.

Differences:

Compared to VITABLOCS FOR CEREC MARK II, MSCB-001 has a higher flexural strength using ISO 6872.

1. Conclusion
  Based on a comparison of intended use, indication for use, composition, and shelf life, GC concludes that MSCB-001 is substantially equivalent to the predicate device (VITABLOCS FOR CEREC MARK II: K022408).

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Table 5.1.1 Comparison Table

	Applicant device	Comparative device	DifferenceY/N	Rationale
Productcategory	CAD/CAM restorative	CAD/CAM restorative
Trade name	MSCB-001	VITABLOCS FOR CERECMARK II (K022408)
ManufacturerIndications	Klema Dentalprodukte1. Metal free indirectrestorations: full crown, inlays,onlays, laminated veneer	Vita ZahnfarbrikFabrication of inlays, onlays,partial and full crowns,endo-crowns of molars, andveneers	Y	We have added theword "metal free" toclarify the classificationof material type theapplicant device is partof. Since the applicant &predicate device areboth metal freeceramics, the technicaldescription & function
Productdescription	MSCB is a block systemconsisting of a porcelain blockcemented to a milling machinespecific mandrel. Thisblock/mandrel is designed tobe milled in a CAD/CAMmilling machine that isprogrammed to fabricate anindirect restoration. Aftermilling, the restoration can becustomized by use ofporcelain stain. The com-position of this product allowsfor milling without need to firein a porcelain furnace.	VITABLOCS are industriallymanufactured, fine-structurefeldspar ceramic blocks used tofabricate inlays, onlays,veneers and crowns withCEREC and inLab CAD/CAMsystems of Sirona DentalSystems GmbH.	Y	have not changed.Though the verbiage isdifferent, the type ofmaterial, Feldspar typeceramic is the same aswell as its form (Blockon mandrel). Bothproducts fabricateindirect restorationusing the sametechnology. Thedifferent term that theapplicant device used is"CAD/CAM millingmachine."
Instructionsfor use	1. Preparation design2. Milling3. Finishing and polishing4. Cementation withsandblasting technique5. Cementation withoutsandblasting technique6. Characterization	Fabrication of the restoration inthe dental laboratory:1. CAD design with inLab 3Dsoftware.2. Milling of the restorationwith inLab.3. Placing the restoration onthe model.4. Finishing & polishing onthe model. Alternatively:characterization/individualization of the shadeFabrication of the restoration inthe dental practice:1. Finishing & polishing.2. Alternatively:Characterization of theshade,individualizing/glazing.3. Adhesive bonding:• Ceramic etching• Silanization	Y	No impact.Different verbiage forsimilar processes.

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	Enamel/dentine etching Adhesive system Adhesive composite Oxygen protection gel 4. Finishing & final polishing
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Differences in verbiage of indications, product description and instructions for use are noted above. Review of these categories between predicate and applicant device demonstrated that these products had similar indications (same clinical utilization), similar description and instructions.

The variations noted and described demonstrate that the predicate and applicant device have similar clinical use that can be manage by the dental professional.

Property /Unit	Standards	Requirements	Test results
			MSCBLT A2	MSCBHT A2	CEREC VITABLOCSMK2
Chemicalsolubility	ISO 6872:2008	Less than 100 µg/cm³	34 µg/cm³	33 µg/cm³	29 µg/cm³
			31 µg/cm³	35 µg/cm³	30 µg/cm³
			29 µg/cm³	39 µg/cm³	35 µg/cm³
		Average	31	35	31
		St. Dev.	2.5	3.0	3.2
Flexuralstrength	ISO 6872:2008	Greater than 100 MPa	210 MPa	207 MPa	154 MPa
			215 MPa	220 MPa	140 MPa
			205 MPa	215 MPa	142 MPa
		Average	210	214	145
		St. Dev.	5	6.5	7.5
Linearthermalexpansion	ISO 6872:2008	TG(°C)+/- 10	470°C	465°C	780°C
			468°C	468°C	790°C
			472°C	475C	785°C
		Average	470°C	469°C	785°
		St. Dev.	2	5	5
Radioactivity	ISO 6872:2008	Radioactivity A ≤ 1.0 By/gan 238U	Conformed	Conformed	Conformed

Table 5.2.1 Summary of Performance Specifications

Comparing test results between applicant and predicate device for the properties of chemical solubility they were statistically equivalent and met or exceeded requirements of ISO 6872:2008.

Comparing test results between application and predicate device for the properties of flexural strength, they were statistically different with MSCB-001 having higher values. Both devices exceeded performance specification minimum.

Comparing test results between predicate and applicant device for linear thermal expansion with a TG of +/-10℃, the standard deviation of products tested were within the SD limitations requirement.

The properties listed, tested and results indicate that the application and predicate device are within the standard ISO 6872:2008. When compared to the predicate device already in the market, the performances of MSCB-001 are at least statistically equivalent and, therefore, can be considered clinically acceptable.

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.