CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.

AI/ML Overview

The provided document describes the 510(k) summary for CERASMART, a pre-cured composite block for milling CAD/CAM indirect dental restorations. The submission focuses on demonstrating substantial equivalence to predicate devices rather than conducting a de novo study with acceptance criteria and a detailed study report. Therefore, many of the requested details about acceptance criteria, study design, and ground truth are not available in this document.

Here's a breakdown of the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds that were met by a study. Instead, it presents performance testing results for the applicant device (CERASMART) and compares them with predicate devices, implying that equivalent or improved performance is desired. The comparison in the table below is qualitative, based on the provided data.

Performance Attribute	Acceptance Criteria (Implied/Compared to Predicate)	Reported Device Performance (CERASMART)
Flexural strength/MPa	(Implied: Comparable to or better than predicate devices)	Performance data is listed in section 8, but specific values are not provided in the summary.
Water Sorption/ug/mm3	(Implied: Comparable to or better than predicate devices)	Lower than 3M Lava Ultimate (K110131) as noted in the "Differences" section. Specific values are not provided.
Solubility/ug/mm3	(Implied: Comparable to or better than predicate devices)	Performance data is listed in section 8, but specific values are not provided in the summary.
Radiopacity	(Implied: Comparable to or better than predicate devices)	Performance data is listed in section 8, but specific values are not provided in the summary.

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

This information is not provided in the 510(k) summary. The document focuses on material properties and comparison to predicate devices, not on a clinical trial or a test set of patient data.

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

This information is not provided as there is no mention of a test set requiring expert ground truth establishment for a diagnostic or AI-driven device. This submission is for a dental restorative material, not a diagnostic tool.

4. Adjudication Method for the Test Set

This information is not provided for the same reasons as above.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic devices or AI algorithms that assist human readers. CERASMART is a dental restorative material.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This is not an AI or algorithm-driven device.

7. The Type of Ground Truth Used

This information is not applicable as there is no diagnostic or AI component requiring a ground truth. The "ground truth" in this context would generally refer to the established physical and chemical properties measured during bench testing of the material itself.

8. The Sample Size for the Training Set

This information is not applicable as there is no AI algorithm being trained.

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

This information is not applicable as there is no AI algorithm being trained.

Summary of Device and Study Focus:

The K133824 submission for CERASMART is a substantial equivalence (SE) application for a Class II dental restorative material. The "study" referenced in the document is primarily bench testing to demonstrate the material's physical and chemical properties (e.g., flexural strength, water sorption, solubility, radiopacity) and comparing them to legally marketed predicate devices. The "acceptance criteria" are implicitly met by demonstrating that CERASMART is "substantially equivalent" to the predicate devices in terms of function, composition, and intended use, with comparable or improved performance in relevant material properties.

The document highlights:

Predicate Devices: 3M ESPE Dental Products LAVA Ultimate (K110131), GC America Inc. MFP-051 (K123631), and GC America Inc. GRADIA CORE (K082171).
Technological Characteristics: All components of CERASMART have been previously used in MFP-051 and GRADIA CORE.
Differences Noted: CERASMART has lower water sorption than 3M Lava Ultimate. MFP-051 and Gradia Core are not pre-cured, unlike CERASMART.
Conclusion: The submission concludes that CERASMART is substantially equivalent to the predicate devices based on its function, composition, and intended use, supported by performance testing data (though specific numerical results are not detailed in this summary).

Summary

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K133824

Section 5 - 510(k) Summary

MAR 1 4 2014

GC AMERICA INC. 3737 WEST 127TH STREET 3000 SIP 11 INOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103

Submitter Information: 1. GC AMERICA INC.
3737 W. 127th Street Alsip, IL 60803 Contact Person: Mark Heiss, D.D.S. Phone: (708) 926-3090 (708) 926-9100 Fax:

Date Prepared: December 12, 2013

1. Device Name:

Proprietary Name:	CERASMART
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690
Product Code:	EBF

3. Predicate Devices:

Company	Device	510(k) No.	Date Cleared
3M ESPE Dental Products	LAVA Ultimate	K110131	1/21/2011
GC America Inc.	MFP-051	K123631	7/23/2013
GC America Inc.	GRADIA CORE	K082171	10/30/2008

1. Description of Device:
  CERASMART is a pre-cured composite block for milling CAD/CAM indirect restorations. The milled device is used for the restorations of both anterior and posterior teeth.
న్. Indications for Use:
The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.
1. Technological characteristics:
  All the components of the applicant device, CERASMART, have already been used in two of the predicate devices (MFP-051 and GRADIA CORE).
1. Substantial equivalence:
  Thus, the new and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices.

Differences:

Compared to 3M Lava Ultimate, Cerasmart has a lower water sorption using ISO 10477. MFP-051 and Gradia Core are not pre-cured. MFP-051 is light cured and Gradia Core is chemical cured.

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1. Performance Testing - Bench: Flexural strength/MPa Water Sorption/ug/mm3 Solubility/ ug/mm3 Radiopacity

PACKAGE

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

SHADE

33 shades

(A1 HT, A2 HT, A3 HT, A3.5 HT, A4 HT, B1 HT, B2 HT, B3 HT, B4 HT, C1 HT, C2 HT, C3 HT, C4 HT, D2 HT, D3 HT, D4 HT, A1 LT, A2 LT, A3 LT, A3.5 LT, A4 LT, B1 LT, B2 LT, B3 LT, B4 LT, C1 LT, C2 LT, C3 LT, C4 LT, D2 LT, D3 LT, D4 LT, BL)

	Applicant device		Comparative device
Productcategory	CAD/CAM restorative	CAD/CAM restorative	Light-curedradiopaqueuniversalcompositerestorative	Light-curedradiopaqueuniversalcompositerestorative
Trade name	CERASMART	LAVA Ultimate(K110131)	MFP-051(K123631)	GRADIA CORE(K082171)
Manufacturer	GC Corporation	3M ESPE	GC Corporation	GC Corporation
Intended use	inlays, onlays,veneers and fullcrown restorations,including crowns onimplants.	inlays, onlays, veneersand full crownrestorations, includingcrowns on implants.	1. Direct restorative forclass 1, 2, 3, 4cavities.2. Direct restorative forwedge-shapeddefects androotsurface cavities.3. Direct restorative forveneers anddiastema closure.	1. Core build-up.2. Post cementation.
Productdescription	CERASMART is apre-cured compositeblock for millingCAD/CAM indirectrestorations. Themilled device is usedfor the restorationsof both anterior andposterior teeth.	The product is a strong,wear-resistant and highlyesthetic mill block thatprovides a fast andeasy-to-use alternative toporcelain blocks formilling CAD/CAMindirect restorations. Thematerial is speciallyprocessed to enhance itspropertiesfor use in CAD/CAMmilling procedures.	MFP-051 is a lightcured nano-filledradiopaque compositeresin filled in a syringeand unitip. Thedevice is used for therestorations of bothanterior and posteriorteeth.	GRADIA COREcartridge is atwo-paste (base andcatalyst) type,dual-cure compositeresin filled in doublesyringe to provideauto-mixing system.The device is used ascomposite resin forrestoration, postcementation and corebuild-up.

Shelf Life: 5 years from date of manufacture

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Image /page/2/Picture/0 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 a stylized symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

March 14, 2014

GC America, Inc. Mark Heiss. DDS Director - Academic & Regulatory Affairs and Professional Relations 3737 West 127th Street Alsip, IL 60803

Re: K133824 Trade/Device Name: CERASMART

Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Codes: EBF, EBG Dated: December 12, 2013 Received: December 17, 2013

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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Page 2 - Dr. Heiss

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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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 Small Manufacturers, International and Consumer Assistance 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,

Erin I. Keith -S

Erin I. Keith, M.S. Acting Division 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):

Device Name: CERASMART_

Indications for Use:

The product is indicated for inlays, onlays, veneers and full crown restorations, including crowns on implants.

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)

Mary S. Runner -S - Drs.nd 2014.03.12 1-04-01 -04-00

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