MFP-051 is a light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip. The device is a universal type. The material is available in 17 shades. The device is used for the restorations of both anterior and posterior teeth.

AI/ML Overview

The provided document is a 510(k) summary for a dental restorative material (MFP-051). It focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria in a clinical or simulated clinical setting. As such, most of the requested information regarding acceptance criteria and performance studies is not available in this document.

Here is a breakdown of the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Test	Acceptance Criteria (Implied by ISO 4049)	Reported Device Performance	Assessment
Substantial Equivalence	Equivalent to predicate devices in function, principle, technology, safety, and intended use.	"The curing mechanism of the new and predicate devices is substantially equivalent... in function, and similar in principle, increr (sic), and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices."	Met
Material Properties (Implied by ISO 4049 and predicate comparison)	Flexural strength, water sorption, and solubility should be equivalent to predicate devices.	"The applicant device also shows equivalence in flexural strength, water sorption and solubility, which indicate the stability of materials in oral environment."	Met
Mechanical/Physical Properties	Compliance with ISO 4049:2009 (Dentistry - Polymer-based restorative materials).	"The applicant device complies with all the requirements of ISO 4049: 2009..."	Met
Components	Components should be previously used in predicate devices or generally accepted for dental materials.	"All the components of the applicant device, MFP-051, have already been used in the predicate devices."	Met
Indications for Use	Similar to predicate devices.	Proposed indications are direct restorative for Class I, II, III, IV, V cavities, wedge-shaped defects and root surface cavities, veneers, and diastema closure, which are consistent with predicate device indications.	Met

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

Not explicitly stated in the document. The document refers to meeting ISO standards and equivalence, implying testing was done, but details about the sample size, test methods, or data provenance (e.g., country of origin, retrospective/prospective) are not provided for specific performance tests. This submission relies on demonstrating compositional and functional similarity to already cleared devices and compliance with an international standard.

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

Not applicable. This document does not describe a study involving expert assessment or "ground truth" establishment in the context of clinical or diagnostic performance. The evaluation is based on material properties and regulatory standards.

4. Adjudication method for the test set:

Not applicable. See point 3.

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:

Not applicable. This device is a dental restorative material, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to AI assistance is irrelevant.

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

Not applicable. This is a physical dental material, not an algorithm.

7. The type of ground truth used:

For the material properties (flexural strength, water sorption, solubility), the "ground truth" would be established by validated laboratory testing methods against the requirements of ISO 4049:2009.
For the claim of "substantial equivalence" of components and indications, the ground truth is the characterization of the predicate devices and their established safety and effectiveness.

8. The sample size for the training set:

Not applicable. This is 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. See point 8.

In summary:

This 510(k) submission for MFP-051 demonstrates substantial equivalence by showing that the device complies with ISO 4049:2009, contains components already used in predicate devices, and shows equivalence in key material properties (flexural strength, water sorption, solubility) to similar legally marketed devices. It does not contain details of specific clinical performance studies with acceptance criteria, sample sizes, or expert adjudication as would be relevant for a diagnostic or AI device. The "acceptance criteria" primarily revolve around meeting an international standard (ISO 4049) and demonstrating technical and functional similarity to predicate devices.

Summary

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K123631

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

JUL 2 3 2013

Section 5 - 510(k) Summary

Submitter Information: ﺴﻴ
- GC AMERICA INC.
  3737 W. 127ª Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 926-9100

November 21, 2012 Date Prepared:

1. Device Name:

Proprietary Name:	MFP-051
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 872.3690
Product Code:	EBF

Predicate Devices: 3.

Company	Device	510(k) No.	Date Cleared
GC America Inc.	GC KALORE (GDLS-200)	K082434	11/14/2008
GC AMERICA, INC	G-aenial Universal Flo(GCUC-505)	K091388	07/22/2009
KERR CORPORATION	PREMISE	K032921	11/13/2003
Ivoclar Vivadent. Inc.	Tetric Evoceram	K042819	11/09/2004

Description of Device: র্য

Indications for Use: 5.

1. Direct restorative for class I, II, III, IV, V cavities.
1. Direct restorative for wedge-shaped defects and root surface cavities.
1. Direct restorative for veneers and diastema closure.
Technological characteristics: 6.

All the components of the applicant device, MFP-051, have already been used in the predicate devices. PREMISE contains barium glass filler, which is one of the components in the proposed device. All the other components are included in GC KALORE (GDLS-200) and G-aenial Universal Flo (GCUC-505).

The curing mechanism of the predicates is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator system.

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Page 2

The applicant device also shows equivalence in flexural strength, water sorption and solubility, which indicate the stability of materials in oral environment.

7. Substantial equivalence:

: . '. :"

The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry -Polymer-based restorative materials).

The curing mechanism of the new and predicate devices is substantially equivalent in Frio caring theefinent onew and predicate devices are the same in function, and similar in primelpte, increre, and intended use. This supports that the compatibility and safety of the applicant device are substantially equivalent to the predicate devices.

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	Applicant device		Comparative device
Trade name	MFP-051	GC KALORE(GDLS-200)	PREMISE	Tetric Evoceram	G-aenial Universal Flo(GCUC-505)
Productcategory	Light-curedradiopaqueuniversalcompositerestorative	Light-curedradiopaque universalcompositerestorative	Universal nano-filledcomposite		UNIVERSALLIGHT-CUREDRADIOPAQUEFLOWABLE COMPOSITE
Company	GC Corporation	GC CorporationK082434	KERR CORPORATIONK032921	Ivoclar Vivadent. Inc.K042819	GC CorporationK091388
510(k) No.
Indicationsfor use	1. Direct restorative forclass I, II, III, IV, Vcavities.	GDLS is a light-curedmicro-filled radiopaqueresin for the restoration ofboth anterior andposterior teeth.GDLS-200 consists of twodelivery systems,Unitip(capsules for singledose) and Syringes. TheGDLS-200 system isavailable in a variety ofshades.	Premise is a dentalcomposite restorativematerial intended to beused in all classes ofcavities.	• Anteriorrestorations(Class III,IV)• Class V restorations(cervical caries, rooterosion, wedge-shapeddefects)• Restorations in theposterior region (Class 1and II)• Veneering of discoloredanterior teeth• Splinting of mobile teeth• Repair of composite andceramic veneers	1. Restoration of class 1,II, III, IV, V cavities.2. Restoration of rootsurface caries3. Restoration ofdeciduous teeth4. Filling tunnel shapedcavities5. Sealing hypersensitiveareas6. Liner/base/filling incavity undercuts7. Sealant8. Splinting mobile teeth9. Additions to compositerestorations
	2. Direct restorative forwedge-shaped defectsand root surfacecavities.
	3. Direct restorative forveneers and diastemaclosure.
Productdescription	MFP-051 is a lightcured nano-filledradiopaque compositeresin filled in a syringeand unitip. Thedevice is used for therestorations of bothanterior and posteriorteeth	GC KALORE(GDLS-200)is a light cured nano-filledradiopaque compositeresin filled in a syringeand unitip. The deviceis used for therestorations of bothanterior and posteriorteeth	PREMISE is a universalnanofilled restorativematerial that offerssuperior esthetics,handling and lowpolymerizationshrinkage all in onesystem.	Tetric EvoCeram is astate-of-the-art, light-curing, radiopaque,nano-hybridcomposite for the directrestorative therapy. TetricEvoCeram cures with lightin the wavelength range of400-500 nm (blue light).	G-aenial Universal Flo isa light cured nano-filledradiopaque compositeresin filled in a syringetopped with a needle tip.The device is a flowablecomposite resin ofnormal consistency.The material is availablein 17 shades.

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			Comparative device
ade name	Applicant deviceMFP-051	GC KALORE(GDLS-200)	PREMISE	Tetric Evoceram	G-aenial Universal Flo(GCUC-505)
Components	* Composite filler* Barium glass* Urethanedimethacrylate(UDMA)* Dimethacrylate* Silicon dioxide* Initiator* Pigment	* Composite filler (withLanthanoid Fluoride)* Strontium/Barium glass* Fluoro-alumino-silicateglass* Urethanedimethacrylate (UDMA)* Dimethacrylate* Silicon dioxide* Photo initiator* Pigment	* Uncured MethacrylateEster* Mineral fillers* Activators* Stabilizers	The monomer matrix:DimethacrylatesThe fillers:barium glass,ytterbium trifluoride,mixed oxide andprepolymerAdditional contents:additives, catalysts,stabilizers andpigments	Triethyleneglycoldimethacrylate,Di-2-Methacryloyloxyethyl2,2,4-Trimethylhexamethylene dicarbamate(Urethanedimethacrylate),Bisphenol A polyethoxymethacrylate (Bis-MEPP),Strontium GlassYtterbium trifluorideCampherquinone2,4,6-Trimethylbenzoyldiphenylphosphine oxideEthylp-Dimethylaminobenzoate2,4-Dimethyl-6, 9-tert-butylphenol2-(2-Hydroxy-5-methylphenyl)-2H-benzotriazole
Instructionsfor use	1. Shade Selection2. Cavity Preparation3. Bonding Treatment4. Placement5. Contouring before LightCuring6. Light Curing7. Finishing and Polishing	1. Shade Selection2. Cavity Preparation3. Bonding Treatment4. Placement5. Contouring before LightCuring6. Light Curing7. Finishing and Polishing	1. RECOMMENDATIONS ONPROPER BONDING2.PLACEMENT OF PREMISECOMPOSITE* Select the desired shade(s).* After placing an increment,stroke the composite to ensuremarginal adaptation.* Light cure each increment for40 seconds.* When multiple surfaces areavailable, cure each surfacefor this recommended time.	1. Shade Selection2. Isolation3. Cavity Preparation4. Pulp protection / Base5. Matrix / Interdental wedge6. Conditioning / Applicationof the bonding agent7. Application of TetricEvoCeram8. Finishing / Checking theocclusion / Polishing	1. Preparations2. Shade Selection3. Cavity Preparation4. Bonding treatment5. Placement of G-ænialUniversal Flo6. Light Curing7. Finishing and Polishing

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three legs and a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is written around the border of the circle.

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

July 23, 2013

GC America, Incorporated Dr. Mark Heiss Director. Regulatory & Academic Affairs and Professional Relations 3737 West 127th Street ALSIP IL 60803

Re: K123631

Trade/Device Name: MFP-051 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: II Product Code: EBF Dated: June 20, 2013 Received: June 21, 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 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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Image /page/6/Picture/7 description: The image shows the text "Mary S. Runner - S". The text is in a bold, sans-serif font. The letters "S.R" are partially obscured by a patterned design. The text is black against a white background.

Kwame Ulmer, 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: MFP-051

Indications for Use:

Direct restorative for class I, II, III, IV, V cavities.

1. Direct restorative for wedge-shaped defects and root surface cavities.

Direct restorative for veneers and diastema closure.

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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Greenças
2013.07.22 13:54:45 -04:00

for M. Susan Runner, DDS, MA

(Division Sign-Off) (Division Sign~Jil)
Division of Anesthestology, General Hospital Infection Control, Dental Devices

510(k) Number,

Page 4.1 of 4.1

Regulation Number and Section

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.