Who is the manufacturer of MFP-051?

GC America, Inc. filed the 510(k) submission for MFP-051 (K123631).

What is the FDA product code for MFP-051?

EBF. It is classified under 21 CFR 872.3690 as a Class 2 device in the Dental panel.

What is the regulatory pathway for MFP-051?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MFP-051?

GC KALORE (GDLS-200) (K082434); G-aenial Universal Flo (GCUC-505) (K091388); PREMISE (K032921); Tetric Evoceram (K042819).

Who can help prepare an FDA 510(k) submission like MFP-051?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MFP-051

K123631 · GC America, Inc. · EBF · Jul 23, 2013 · Dental

Device Facts

Record ID	K123631
Device Name	MFP-051
Applicant	GC America, Inc.
Product Code	EBF · Dental
Decision Date	Jul 23, 2013
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.3690
Device Class	Class 2
Attributes	Therapeutic

Indications for Use

1. Direct restorative for class I, II, III, IV, V cavities. 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure.

Device Story

MFP-051 is a light-cured, nano-filled, radiopaque composite resin used by dental professionals for direct restorations of anterior and posterior teeth. The material is supplied in syringes or unitips and is available in 17 shades. The device is applied to the tooth cavity, contoured, and then polymerized using a light-curing system (photo-initiator based). This restoration process restores tooth structure, function, and aesthetics for patients with cavities, defects, or aesthetic concerns. The device provides stability in the oral environment, evidenced by its flexural strength, water sorption, and solubility characteristics.

Clinical Evidence

Bench testing only. The device demonstrated substantial equivalence through physical and chemical property testing, including flexural strength, water sorption, and solubility, in compliance with ISO 4049:2009 standards.

Technological Characteristics

Light-cured, nano-filled, radiopaque composite resin. Composition includes composite filler, barium glass, UDMA, dimethacrylate, silicon dioxide, initiator, and pigment. Polymerization via photo-initiator system (blue light, 400-500 nm). Form factor: syringe or unitip. Complies with ISO 4049:2009.

Indications for Use

Indicated for patients requiring direct dental restorations for Class I, II, III, IV, and V cavities, wedge-shaped defects, root surface cavities, veneers, and diastema closure.

Regulatory Classification

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.

Predicate Devices

GC KALORE (GDLS-200) (K082434)
G-aenial Universal Flo (GCUC-505) (K091388)
PREMISE (K032921)
Tetric Evoceram (K042819)

Submission Summary (Full Text)

{0}------------------------------------------------ K123631 GC 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: - 2. 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 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. ### Indications for Use: 5. - 1. Direct restorative for class I, II, III, IV, V cavities. - 2. Direct restorative for wedge-shaped defects and root surface cavities. - 3. 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. Image /page/0/Picture/21 description: The image contains two logos. The logo on the left is a diamond shape with the words "CERTIFIED TO ASTM F963" inside. Below the diamond is a banner with the word "MATERIAL". The logo on the right has the letters "DTA" in bold, with the word "LICENSED" above it. The logo on the right is surrounded by a dotted border. {1}------------------------------------------------ # 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. {2}------------------------------------------------ | | Applicant device | | Comparative device | | | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Trade name | MFP-051 | GC KALORE(GDLS-200) | PREMISE | Tetric Evoceram | G-aenial Universal Flo (GCUC-505) | | Product category | Light-cured radiopaque universal composite restorative | Light-cured radiopaque universal composite restorative | Universal nano-filled composite | | UNIVERSAL LIGHT-CURED RADIOPAQUE FLOWABLE COMPOSITE | | Company | GC Corporation | GC Corporation K082434 | KERR CORPORATION K032921 | Ivoclar Vivadent. Inc. K042819 | GC Corporation K091388 | | 510(k) No. | | | | | | | Indications for use | 1. Direct restorative for class I, II, III, IV, V cavities. | GDLS is a light-cured micro-filled radiopaque resin for the restoration of both anterior and posterior teeth. GDLS-200 consists of two delivery systems, Unitip(capsules for single dose) and Syringes. The GDLS-200 system is available in a variety of shades. | Premise is a dental composite restorative material intended to be used in all classes of cavities. | • Anterior restorations(Class III, IV) • Class V restorations (cervical caries, root erosion, wedge-shaped defects) • Restorations in the posterior region (Class 1 and II) • Veneering of discolored anterior teeth • Splinting of mobile teeth • Repair of composite and ceramic veneers | 1. Restoration of class 1, II, III, IV, V cavities. 2. Restoration of root surface caries 3. Restoration of deciduous teeth 4. Filling tunnel shaped cavities 5. Sealing hypersensitive areas 6. Liner/base/filling in cavity undercuts 7. Sealant 8. Splinting mobile teeth 9. Additions to composite restorations | | | 2. Direct restorative for wedge-shaped defects and root surface cavities. | | | | | | | 3. Direct restorative for veneers and diastema closure. | | | | | | Product description | MFP-051 is a light cured nano-filled radiopaque composite resin filled in a syringe and unitip. The device is used for the restorations of both anterior and posterior teeth | GC KALORE(GDLS-200) is a light cured nano-filled radiopaque composite resin filled in a syringe and unitip. The device is used for the restorations of both anterior and posterior teeth | PREMISE is a universal nanofilled restorative material that offers superior esthetics, handling and low polymerization shrinkage all in one system. | Tetric EvoCeram is a state-of-the-art, light- curing, radiopaque, nano-hybrid composite for the direct restorative therapy. Tetric EvoCeram cures with light in the wavelength range of 400-500 nm (blue light). | G-aenial Universal Flo is a light cured nano-filled radiopaque composite resin filled in a syringe topped with a needle tip. The device is a flowable composite resin of normal consistency. The material is available in 17 shades. | . {3}------------------------------------------------ | | | | Comparative device | | | |-------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | ade name | Applicant device MFP-051 | GC KALORE(GDLS-200) | PREMISE | Tetric Evoceram | G-aenial Universal Flo (GCUC-505) | | Components | * Composite filler * Barium glass * Urethane dimethacrylate (UDMA) * Dimethacrylate * Silicon dioxide * Initiator * Pigment | * Composite filler (with Lanthanoid Fluoride) * Strontium/Barium glass * Fluoro-alumino-silicate glass * Urethane dimethacrylate (UDMA) * Dimethacrylate * Silicon dioxide * Photo initiator * Pigment | * Uncured Methacrylate Ester * Mineral fillers * Activators * Stabilizers | The monomer matrix: Dimethacrylates The fillers: barium glass, ytterbium trifluoride, mixed oxide and prepolymer Additional contents: additives, catalysts, stabilizers and pigments | Triethyleneglycol dimethacrylate, Di-2-Methacryloyloxyethyl 2,2,4-Trimethylhexamethy lene dicarbamate (Urethane dimethacrylate), Bisphenol A polyethoxy methacrylate (Bis-MEPP), Strontium Glass Ytterbium trifluoride Campherquinone 2,4,6-Trimethylbenzoyldip henylphosphine oxide Ethyl p-Dimethylaminobenzoate 2,4-Dimethyl-6, 9-tert-butyl phenol 2-(2-Hydroxy-5-methylphe nyl)-2H-benzotriazole | | Instructions for use | 1. Shade Selection 2. Cavity Preparation 3. Bonding Treatment 4. Placement 5. Contouring before Light Curing 6. Light Curing 7. Finishing and Polishing | 1. Shade Selection 2. Cavity Preparation 3. Bonding Treatment 4. Placement 5. Contouring before Light Curing 6. Light Curing 7. Finishing and Polishing | 1. RECOMMENDATIONS ON PROPER BONDING 2.PLACEMENT OF PREMISE COMPOSITE * Select the desired shade(s). * After placing an increment, stroke the composite to ensure marginal adaptation. * Light cure each increment for 40 seconds. * When multiple surfaces are available, cure each surface for this recommended time. | 1. Shade Selection 2. Isolation 3. Cavity Preparation 4. Pulp protection / Base 5. Matrix / Interdental wedge 6. Conditioning / Application of the bonding agent 7. Application of Tetric EvoCeram 8. Finishing / Checking the occlusion / Polishing | 1. Preparations 2. Shade Selection 3. Cavity Preparation 4. Bonding treatment 5. Placement of G-ænial Universal Flo 6. Light Curing 7. Finishing and Polishing | : . . {4}------------------------------------------------ | V ) | |---------| | age | | D. T | glass filled in the pplicated online online operations devices by producted by Prodicate devices devices devices devices de virginale de mailiar la provincial in mala include # రం bstonnia equivalez. o appinante estiblies with all the senisterialiy equivalien in principes tresint many of the more many and more many and manar and rices arbest in thorion - fe Evaluation and Storage Conditio б - - Life 3 years n a cool and dark place. 4-25°C (39.2 {5}------------------------------------------------ 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. {6}------------------------------------------------ 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 {7}------------------------------------------------ Section 4 - Indications for Use Statement Indications for Use 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________ Device Name: MFP-051 Indications for Use: 1. Direct restorative for class I, II, III, IV, V cavities. - 2. Direct restorative for wedge-shaped defects and root surface cavities. 3. Direct restorative for veneers and diastema closure. Prescription Use _ X (Part 21 CFR 801 Subpart D) AND/OR 4 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

MFP-051

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Indications for Use

Device Story

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Submission Summary (Full Text)

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Indications for Use

Device Story

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Indications for Use

Regulatory Classification

Identification

Predicate Devices

Submission Summary (Full Text)

Panel 1

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