NMF004A

K173500 · GC America, Inc. · EBF · Mar 8, 2018 · Dental

Device Facts

• Record ID: K173500
• Device Name: NMF004A
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Mar 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

1. Liner or base 2. Blocking out undercuts 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. Direct restorative for Class I, II, III, IV, V cavities 7. Core build-up

Device Story

NMF004A is a light-cured, nano-filled, radiopaque composite resin restorative material. Supplied in a syringe with dispensing tips, it is applied by dental professionals in a clinical setting. The material is placed into prepared tooth cavities or used for core build-up and then cured using a dental light-curing unit. The polymerization of methacrylate ester monomers, initiated by a photo-initiator system, hardens the material to restore tooth structure or seal defects. The device provides a flowable consistency for ease of placement. Clinical benefits include restoration of tooth form and function, protection of hypersensitive areas, and repair of existing restorations. Healthcare providers use the output (hardened resin) to restore dental anatomy and improve patient oral health.

Clinical Evidence

Bench testing only. The device was evaluated for compliance with ISO 4049:2009. Results confirmed: depth of cure (>1.5mm for opaque, >2.0mm for others), flexural strength (>80 MPa), water sorption (<40 µg/mm³), solubility (<7.5 µg/mm³), color stability, and radiopacity (greater than aluminum).

Technological Characteristics

Light-cured, nano-filled, radiopaque composite resin. Contains methacrylate ester monomers and a photo-initiator system. Includes methacryloxyoctyltrimethoxysilane coupling agent. Form factor: syringe-delivered flowable paste. Complies with ISO 4049:2009 standards for polymer-based restorative materials.

Indications for Use

Indicated for dental patients requiring restorative procedures including liner/base, undercut blocking, repair of aesthetic restorations/temporary crowns/bridges, sealing hypersensitive areas, fissure sealing, Class I-V cavity restorations, and core build-up.

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

• G-aenial Universal Flo (K091388)

Reference Devices

• G-aenial Sculpt (K123631)
• Kalore (K082434)

Submission Summary (Full Text)

{0}------------------------------------------------

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);

{1}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K173500

Device Name NMF004A

Indications for Use (Describe)

- 1. Liner or base
- 2. Blocking out undercuts
- 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel
- 4. Sealing hypersensitive areas
- 5. Fissure sealant
- 6. Direct restorative for Class I, II, III, IV, V cavities
- 7. 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)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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 [phone]
FAX [phone]
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: | [phone] |
| Fax: | [phone] |
| Alternate Contact: | Lori Rietman |
| Alternate Phone: | [phone] |
| | |

Date Prepared: November 9, 2017

- 2. Device Name:

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

- 3. Predicate Devices:

| Company | Device | Primary/<br>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.
- 2. Blocking out undercuts.
- 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins when margins are in enamel.
- 4. Sealing hypersensitive areas.
- 5. Fissure sealant.
- 6. Direct restorative for Class I, II, III, IV, V cavities.
- 7. Core build-up

{4}------------------------------------------------

#### 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:

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

- 2. 30 dispensing tips, 2 light protective covers
- 9. 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.

{5}------------------------------------------------

| Table 5.1 Substantial equivalence to the reference predicate devices | | | | |
|----------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Applicant device | Primary Predicate Device | Reference Predicate Device | Reference Predicate Device |
| Product<br>category | Tooth shade resin material, Class II | Tooth shade resin material, Class II | Tooth shade resin material, Class II | Tooth shade resin material,<br>Class II |
| Trade name | NMF004A | GCUC-505 (G-aenial Universal Flo)<br>K091388 | MFP-051 (G-aenial Sculpt) K123631 | GDLS-200 (GC KALORE)<br>K082434 |
| Manufacturer | GC Corporation | GC Corporation | GC Corporation | GC Corporation |
| Indications for<br>use | 1. Liner or base<br>2. Blocking out undercuts.<br>3. Repair of (in) direct aesthetic<br>restorations, temporary crown &<br>bridge, defect margins when margins<br>are in enamel.<br>4. Sealing hypersensitive areas.<br>5. Fissure sealant.<br>6. Direct restorative for Class I, II, III, IV,<br>V cavities<br>7. Core build-up | 1. Liner or base<br>2. Blocking out undercuts<br>3. Repair of (in) direct aesthetic<br>restorations, temporary crown &<br>bridge, defect margins when<br>margins are in enamel<br>4. Sealing hypersensitive areas<br>5. Fissure sealant<br>6. Direct restorative for <b>small</b><br>Class I, II, III, IV, V cavities | 1. Direct restorative for class I, II, III, IV,<br>V cavities.<br>2. Direct restorative for wedge-shaped<br>defects and root surface cavities.<br>3. Direct restorative for veneers and<br>diastema closure. | 1. Direct restorative for Class I, II,<br>III, IV, V cavities.<br>2. Direct restorative for<br>wedge-shaped defects and root<br>surface cavities.<br>3. Direct restorative for veneers<br>and diastema closure |
| Product<br>description | NMF004A is a light-cured nano-filled<br>radiopaque composite restorative resin<br>filled in a syringe. For extrusion, a filling<br>tip is attached to top of a syringe. The<br>device is flowable composite resin<br>formulated with high consistency. | G-aenial Universal Flo is a light-cured<br>nano-filled radiopaque composite<br>restorative resin filled in a syringe. For<br>extrusion, a filling tip is attached to top<br>of a syringe. The device is flowable<br>composite resin formulated with high<br>consistency. | MFP-051 is a light-cured nano-filled<br>radiopaque composite resin filled in a<br>syringe and unitip. The device is used<br>for the restorations of both anterior and<br>posterior teeth | GDLS is a light-cured micro-filled<br>radiopaque resin for the<br>restoration of both anterior and<br>posterior teeth. GDLS-200<br>consists of two delivery systems,<br>Unitip (capsules for single dose)<br>and Syringes. The GDLS-200<br>system is available in a variety of<br>shades. |
| Instructions for<br>Use | 1. Preparations<br>2. Shade Selection<br>3. Cavity Preparation<br>4. Bonding treatment<br>5. Placement<br>6. Light Curing<br>7. Finishing and Polishing | 1. Preparations<br>2. Shade Selection<br>3. Cavity Preparation<br>4. Bonding treatment<br>5. Placement<br>6. Light Curing<br>7. Finishing and Polishing | 1. Shade Selection<br>2. Cavity Preparation<br>3. Bonding Treatment<br>4. Placement<br>5. Contouring before Light Curing<br>6. Light Curing<br>7. Finishing and Polishing | 1. Shade Selection<br>2. Cavity Preparation<br>3. Bonding Treatment<br>4. Placement<br>5. Contouring before Light Curing<br>6. Light Curing<br>7. Finishing and Polishing |
| Technological<br>Characteristics | All the compounds found in the<br>applicant device, NMF004A, have<br>already been used in the predicate<br>devices except for<br>methacryloxyoctyltrimethoxysilane.<br>The curing mechanism of the<br>predicates and NMF004A is<br>polymerization of uncured methacrylate<br>ester monomers. This reaction is<br>caused by photo initiator system. | All the components of the applicant<br>device, GCUC-505, have already<br>been used in the predicate devices.<br>The curing mechanism of the<br>predicates and GCUC-505 is<br>polymerization of uncured<br>methacrylate ester monomers. This<br>reaction is caused by photo initiator<br>system. | All the components of the applicant device,<br>MFP-051, have already been used in the<br>predicate devices. PREMISE contains<br>barium glass filler, which is one of the<br>components in the proposed device. All<br>the other components are included in GC<br>KALORE (GDLS-200) and G-aenial<br>Universal Flo (GCUC-505). The curing<br>mechanism of the predicates is<br>polymerization of uncured meth-acrylate<br>ester monomers. This reaction is caused<br>by photo initiator system. | The curing mechanism of the<br>predicates and GCUC-505 is<br>polymerization of uncured<br>methacrylate ester monomers.<br>This reaction is caused by photo<br>initiator system. |

## Table 5.1 Substantial equivalence to the reference predicate devices

{6}------------------------------------------------

#### 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<br>ambient light | Remain physically homogeneous |
| 2 | Depth of cure | Opaque shade: > 1.5mm<br>Other shade: > 2.0mm |
| 3 | Flexural strength | > 80 MPa |
| 4 | Water sorption | < 40 µg/mm³ |
| 5 | Solubility | < 7.5 µg/mm³ |
| 6 | Color stability after<br>irradiation and<br>water sorption | No more than slight change in color. |
| 7 | Radiopacity | Greater than the same thickness of aluminum |

## Differences

The following differences may be noted between the predicate devices and NMF004A:

- · A coupling agent for NMF004A is different from that for predicate devices such as G-aenial Universal Flo, G-aenial Sculpt and Kalore (see section 12).
#### 10. Conclusion:

Based on similarities in intended use, mode of action, chemical composition, and performance testing, NMF004A is substantially equivalent to the selected predicate devices.