Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and intended use are for a standard dental composite resin, and there is no mention of AI, ML, image processing, or any data-driven algorithms.

Therapeutic

No.
The device is a restorative material for dental cavities, not a therapeutic device designed to treat a disease or medical condition.

Diagnostic

No
The device is described as a "light-cured, nano-filled radiopaque composite resin" used for "restorations of both anterior and posterior teeth." This indicates it is a material used for physical repair or filling, not for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light-cured, nano-filled radiopaque composite resin filled in either a syringe or unitip," which are physical materials and delivery mechanisms, not software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses listed are all related to the direct restoration of teeth. This involves physically filling cavities and defects in the mouth.
Device Description: The device is described as a light-cured, nano-filled composite resin used for dental restorations. This is a material applied directly to the patient's teeth.
Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) in vitro (outside the body) to provide information about a patient's health status, diagnosis, or treatment.

IVDs are typically used in laboratories or point-of-care settings to analyze biological samples. This device is a dental restorative material used directly on the patient.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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

Product codes

EBF

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

anterior and posterior teeth

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K082434, K091388, K032921, K042819

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

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:

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

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.
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.

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.

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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)
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.

Restoration of root
surface caries
Restoration of
deciduous teeth
Filling tunnel shaped
cavities
Sealing hypersensitive
areas
Liner/base/filling in
cavity undercuts
Sealant
Splinting mobile teeth
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

Isolation
Cavity Preparation
Pulp protection / Base
Matrix / Interdental wedge
Conditioning / Application
of the bonding agent
Application of Tetric
EvoCeram
Finishing / Checking the
occlusion / Polishing | 1. Preparations
Shade Selection
Cavity Preparation
Bonding treatment
Placement of G-ænial
Universal Flo
Light Curing
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.

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:

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

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