Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on material properties and clinical applications of a composite resin, with no mention of AI or ML.

Therapeutic

No.
This device is a dental restorative material, not a therapeutic device. It is used to repair dental structures rather than treat a disease or condition. Its performance studies focus on material properties like strength, solubility, and radiopacity, consistent with a restorative material.

Diagnostic

No
The device is described as a light-cured nano-filled radiopaque composite resin used for restorations, which indicates a therapeutic or restorative function rather than a diagnostic one. Its intended uses (e.g., direct restorative for cavities, core build-up) are all treatment-oriented.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "light cured nano-filled radiopaque composite resin filled in a syringe," which is a physical material, 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 direct dental procedures performed on a patient's teeth (restorations, sealing, core build-up, etc.). These are clinical procedures, not laboratory tests performed on samples taken from the body.
Device Description: The device is a composite resin used for filling cavities and restoring teeth. This is a material used in the body, not a reagent or instrument used to analyze biological samples outside the body.
Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on laboratory testing.

IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

1. Liner or base
1. Blocking out undercuts
1. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
1. Sealing hypersensitive areas
1. Fissure sealant
1. Direct restorative for Class I, II, III, IV, V cavities
1. Core build-up

Product codes (comma separated list FDA assigned to the subject device)

EBF

Device Description

NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

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)

Performance testing includes:

Sensitivity to ambient light
Depth of cure
Flexural strength
Water sorption
Solubility
Color stability after irradiation and water sorption
Radiopacity

The device complies with ISO 4049: 2009 (Dentistry - Polymer-based restorative materials).

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

Sensitivity to ambient light: Remain physically homogeneous
Depth of cure: Opaque shade: > 1.5mm, Other shade: > 2.0mm
Flexural strength: > 80 MPa
Water sorption:

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

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

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

March 8, 2018

Re: K173500

Trade/Device Name: Nmf004a Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth Shade Resin Material Regulatory Class: Class II Product Code: EBF Dated: December 19, 2017 Received: December 20, 2017

Dear Mark 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.

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 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);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

for Tina Kiang, Ph.D. Acting 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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Indications for Use

510(k) Number (if known) K173500

Device Name NMF004A

Indications for Use (Describe)

1. Liner or base
1. Blocking out undercuts
1. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
1. Sealing hypersensitive areas
1. Fissure sealant
1. Direct restorative for Class I, II, III, IV, V cavities
1. Core build-up

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K173500

Image /page/3/Picture/2 description: The image shows the letters 'GC' in a stylized, sans-serif font. The letters are a teal color, and there are single quotation marks before and after the letters. The letters are bold and slightly italicized, giving them a dynamic appearance. The background is plain white.

GC AMERICA INC.

3737 W 127th STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX (708) 926-9100
www.gcamerica.com

Section 5 - 510(k) Summary

1. Submitter Information:
  GC America Inc. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S.
Phone:	(708) 926-3090
Fax:	(708) 926-9100
Alternate Contact:	Lori Rietman
Alternate Phone:	(708) 926-3092

Date Prepared: November 9, 2017

1. Device Name:

Proprietary Name:	NMF004A
Classification Name:	Tooth shade resin material
Device Classification:	Class II, 21 CFR 872.3690
Product Code:	EBF

1. Predicate Devices:

| Company | Device | Primary/
Reference | 510(k) No. | Date Cleared |
|-----------------|-----------------------------------|-----------------------|------------|--------------|
| GC America Inc. | (GCUC-505) G-aenial Universal Flo | Primary | K091388 | 7/22/2009 |
| GC America Inc. | (MFP-051) G-aenial Sculpt | Reference | K123631 | 7/23/2013 |
| GC America Inc. | Kalore (GDLS-200) | Reference | K082434 | 11/14/2008 |

4. Description of Device:

NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.

5. Indications for Use:

1. Liner or base.
1. Blocking out undercuts.
1. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel.
1. Sealing hypersensitive areas.
1. Fissure sealant.
1. Direct restorative for Class I, II, III, IV, V cavities.
1. Core build-up

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6. Performance Bench Tests:

It is confirmed that the device conforms to the required specifications and is suitable for its intended use. Performance testing includes:

Sensitivity to ambient light ●
. Depth of cure
Flexural strength ●
Water sorption ●
Solubility ●
Color stability after irradiation and water sorption ●
. Radiopacity

7. Packaging:

Syringe 1.7g (1.0mL), 20 dispensing tips, 1 light protective cover Dispensing tip package:

1. 30 dispensing tips, 2 light protective covers
1. Shelf Life Evaluation and Storage Conditions:
- Shelf Life 3 years ı
- Recommended for optimal performance, store in a cool and dark place. 4-25°C (39.2 77.0°F) । away from high temperatures or direct sunlight.

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Table 5.1 Substantial equivalence to the reference predicate devices
	Applicant device	Primary Predicate Device	Reference Predicate Device	Reference Predicate Device
Product
category	Tooth shade resin material, Class II	Tooth shade resin material, Class II	Tooth shade resin material, Class II	Tooth shade resin material,
Class II
Trade name	NMF004A	GCUC-505 (G-aenial Universal Flo)
K091388	MFP-051 (G-aenial Sculpt) K123631	GDLS-200 (GC KALORE)
K082434
Manufacturer	GC Corporation	GC Corporation	GC Corporation	GC Corporation
Indications for
use	1. Liner or base

Blocking out undercuts.
Repair of (in) direct aesthetic
restorations, temporary crown &
bridge, defect margins when margins
are in enamel.
Sealing hypersensitive areas.
Fissure sealant.
Direct restorative for Class I, II, III, IV,
V cavities
Core build-up | 1. Liner or base
Blocking out undercuts
Repair of (in) direct aesthetic
restorations, temporary crown &
bridge, defect margins when
margins are in enamel
Sealing hypersensitive areas
Fissure sealant
Direct restorative for small
Class I, II, III, IV, V cavities | 1. 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. | 1. 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
description | NMF004A is a light-cured nano-filled
radiopaque composite restorative resin
filled in a syringe. For extrusion, a filling
tip is attached to top of a syringe. The
device is flowable composite resin
formulated with high consistency. | G-aenial Universal Flo is a light-cured
nano-filled radiopaque composite
restorative resin filled in a syringe. For
extrusion, a filling tip is attached to top
of a syringe. The device is flowable
composite resin formulated with high
consistency. | 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 | 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. |
| Instructions for
Use | 1. Preparations
Shade Selection
Cavity Preparation
Bonding treatment
Placement
Light Curing
Finishing and Polishing | 1. Preparations
Shade Selection
Cavity Preparation
Bonding treatment
Placement
Light Curing
Finishing and Polishing | 1. Shade Selection
Cavity Preparation
Bonding Treatment
Placement
Contouring before Light Curing
Light Curing
Finishing and Polishing | 1. Shade Selection
Cavity Preparation
Bonding Treatment
Placement
Contouring before Light Curing
Light Curing
Finishing and Polishing |
| Technological
Characteristics | All the compounds found in the
applicant device, NMF004A, have
already been used in the predicate
devices except for
methacryloxyoctyltrimethoxysilane.
The curing mechanism of the
predicates and NMF004A is
polymerization of uncured methacrylate
ester monomers. This reaction is
caused by photo initiator system. | All the components of the applicant
device, GCUC-505, have already
been used in the predicate devices.
The curing mechanism of the
predicates and GCUC-505 is
polymerization of uncured
methacrylate ester monomers. This
reaction is caused by photo initiator
system. | 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 meth-acrylate
ester monomers. This reaction is caused
by photo initiator system. | The curing mechanism of the
predicates and GCUC-505 is
polymerization of uncured
methacrylate ester monomers.
This reaction is caused by photo
initiator system. |

Table 5.1 Substantial equivalence to the reference predicate devices

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8. Substantial equivalence:

The curing mechanism of the new and predicate devices is substantially equivalent in principle. Therefore, 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.

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

	Property	Requirements
1	Sensitivity to
ambient light	Remain physically homogeneous
2	Depth of cure	Opaque shade: > 1.5mm
Other shade: > 2.0mm
3	Flexural strength	> 80 MPa
4	Water sorption