NMF004A

• K Number: K173500
• Device Name: NMF004A
• Manufacturer: GC America Inc.
• Date Cleared: 2018-03-08 ( 115 days)
• Product Code: EBF
• Regulation Number: 872.3690
• Type: Traditional
• Panel: Dental
• Reference & Predicate Devices: K123631 , K082434 , K091388
• Predicate For: K250317 , K251946

Intended Use

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

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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a dental device named NMF004A. This document asserts the device's substantial equivalence to previously cleared predicate devices by outlining its characteristics, indications for use, and performance bench tests against a recognized standard (ISO 4049:2009).

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the provided text:

1. A table of acceptance criteria and the reported device performance:

The document states that "The applicant device complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials)." While specific measured values for NMF004A are not explicitly provided in the table, the text implies that NMF004A's performance meets these requirements. The table below presents the acceptance criteria from ISO 4049:2009 as listed in the document.

Property	Acceptance Criteria (from ISO 4049:2009)	Reported Device Performance (NMF004A)
Sensitivity to ambient light	Remain physically homogeneous	Complies
Depth of cure	Opaque shade: > 1.5mmOther shade: > 2.0mm	Complies
Flexural strength	> 80 MPa	Complies
Water sorption	< 40 µg/mm³	Complies
Solubility	< 7.5 µg/mm³	Complies
Color stability after irradiation and water sorption	No more than slight change in color.	Complies
Radiopacity	Greater than the same thickness of aluminum	Complies

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

The document does not specify the sample sizes used for the performance bench tests. It also does not provide information regarding the data provenance (e.g., country of origin, retrospective or prospective nature).

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

This information is not provided. The "performance bench tests" described are laboratory tests against ISO standards, not studies involving expert evaluation of clinical data for ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable and therefore not provided in the document. The performance tests are objective measurements against ISO standards, not subjective evaluations requiring adjudication.

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:

This information is not provided and is not applicable. The device, NMF004A, is a tooth shade resin material, not an AI-assisted diagnostic tool or an imaging device. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant.

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

This information is not provided and is not applicable. NMF004A is a physical dental material, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the performance bench tests is the established requirements of the ISO 4049:2009 standard (Dentistry - Polymer-based restorative materials). These are objective, scientifically defined physical and chemical properties of dental materials.

8. The sample size for the training set:

This information is not provided and is not applicable. The device is a physical material, not a machine learning model; therefore, it does not have a "training set."

9. How the ground truth for the training set was established:

This information is not provided and is not applicable for the reasons stated above.

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 ([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

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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)

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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 [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/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

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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:

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.

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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
Productcategory	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 foruse	1. Liner or base2. Blocking out undercuts.3. Repair of (in) direct aestheticrestorations, temporary crown &bridge, defect margins when marginsare in enamel.4. Sealing hypersensitive areas.5. Fissure sealant.6. Direct restorative for Class I, II, III, IV,V cavities7. Core build-up	1. Liner or base2. Blocking out undercuts3. Repair of (in) direct aestheticrestorations, temporary crown &bridge, defect margins whenmargins are in enamel4. Sealing hypersensitive areas5. Fissure sealant6. Direct restorative for smallClass I, II, III, IV, V cavities	1. Direct restorative for class I, II, III, IV,V cavities.2. Direct restorative for wedge-shapeddefects and root surface cavities.3. Direct restorative for veneers anddiastema closure.	1. Direct restorative for Class I, II,III, IV, V cavities.2. Direct restorative forwedge-shaped defects and rootsurface cavities.3. Direct restorative for veneersand diastema closure
Productdescription	NMF004A is a light-cured nano-filledradiopaque composite restorative resinfilled in a syringe. For extrusion, a fillingtip is attached to top of a syringe. Thedevice is flowable composite resinformulated with high consistency.	G-aenial Universal Flo is a light-curednano-filled radiopaque compositerestorative resin filled in a syringe. Forextrusion, a filling tip is attached to topof a syringe. The device is flowablecomposite resin formulated with highconsistency.	MFP-051 is a light-cured nano-filledradiopaque composite resin filled in asyringe and unitip. The device is usedfor the restorations of both anterior andposterior teeth	GDLS is a light-cured micro-filledradiopaque resin for therestoration of both anterior andposterior teeth. GDLS-200consists of two delivery systems,Unitip (capsules for single dose)and Syringes. The GDLS-200system is available in a variety ofshades.
Instructions forUse	1. Preparations2. Shade Selection3. Cavity Preparation4. Bonding treatment5. Placement6. Light Curing7. Finishing and Polishing	1. Preparations2. Shade Selection3. Cavity Preparation4. Bonding treatment5. Placement6. Light Curing7. Finishing and Polishing	1. Shade Selection2. Cavity Preparation3. Bonding Treatment4. Placement5. Contouring before Light Curing6. Light Curing7. Finishing and Polishing	1. Shade Selection2. Cavity Preparation3. Bonding Treatment4. Placement5. Contouring before Light Curing6. Light Curing7. Finishing and Polishing
TechnologicalCharacteristics	All the compounds found in theapplicant device, NMF004A, havealready been used in the predicatedevices except formethacryloxyoctyltrimethoxysilane.The curing mechanism of thepredicates and NMF004A ispolymerization of uncured methacrylateester monomers. This reaction iscaused by photo initiator system.	All the components of the applicantdevice, GCUC-505, have alreadybeen used in the predicate devices.The curing mechanism of thepredicates and GCUC-505 ispolymerization of uncuredmethacrylate ester monomers. Thisreaction is caused by photo initiatorsystem.	All the components of the applicant device,MFP-051, have already been used in thepredicate devices. PREMISE containsbarium glass filler, which is one of thecomponents in the proposed device. Allthe other components are included in GCKALORE (GDLS-200) and G-aenialUniversal Flo (GCUC-505). The curingmechanism of the predicates ispolymerization of uncured meth-acrylateester monomers. This reaction is causedby photo initiator system.	The curing mechanism of thepredicates and GCUC-505 ispolymerization of uncuredmethacrylate ester monomers.This reaction is caused by photoinitiator 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 toambient light	Remain physically homogeneous
2	Depth of cure	Opaque shade: > 1.5mmOther shade: > 2.0mm
3	Flexural strength	> 80 MPa
4	Water sorption	< 40 µg/mm³
5	Solubility	< 7.5 µg/mm³
6	Color stability afterirradiation andwater 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.

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.