Liner or base
Blocking out undercuts
Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
Sealing hypersensitive areas
Fissure sealant
Direct restorative for small Class I, II, III, IV, and V cavities

Device Description

HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is a universal type. The material is available in 8 shades: A1, A2, A3, A3.5, A4, A02, AO3 and CV

AI/ML Overview

The provided document is a 510(k) summary for a dental resin material, HTFX-222. It focuses on demonstrating substantial equivalence to predicate devices rather than describing a performance study of an AI-powered diagnostic device. Therefore, the specific information requested about acceptance criteria, study design, expert involvement, and AI performance metrics is not applicable to this document.

However, I can extract the information that is present regarding the device's technical specifications and how its performance was verified against an industry standard.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are derived from the international standard ISO 4049:2009 (Dentistry - Polymer-based restorative materials). The document states that the device was tested and confirmed to meet these requirements.

Acceptance Criteria (from ISO 4049:2009)	Reported Device Performance (HTFX-222)
Sensitivity to ambient light	Conforms to Required Specifications
Depth of cure	Conforms to Required Specifications (Differences noted from predicates)
Flexural strength	Conforms to Required Specifications (Differences noted from predicates)
Water sorption	Conforms to Required Specifications (Differences noted from predicates)
Solubility	Conforms to Required Specifications
Color stability after irradiation and water sorption	Conforms to Required Specifications
Radiopacity	Conforms to Required Specifications

Note: The document explicitly states, "It is confirmed that the device conforms to the required specifications of ISO 4049:2009 and is suitable for its intended use." Differences in Depth of Cure, Flexural Strength, and Water Sorption are noted when compared to predicate devices, but the implication is that these still fall within the acceptable parameters of ISO 4049.

2. Sample Size Used for the Test Set and Data Provenance

Not applicable. This is a material science study, not a study involving patient data or a "test set" in the context of an AI device. The tests are performed on material specimens.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. Ground truth for material properties is established through standardized laboratory testing methods defined by ISO 4049:2009, not by expert consensus in the typical sense of medical image interpretation.

4. Adjudication Method for the Test Set

Not applicable. Material property tests are objective measurements, not subject to adjudication by multiple parties.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This is not an AI-powered diagnostic device, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No. This is a material, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance of HTFX-222 is based on standardized laboratory measurements and accepted industry specifications as defined by ISO 4049:2009. These are objective physical and chemical properties of the material.

8. The Sample Size for the Training Set

Not applicable. This is a material testing document, not a machine learning study. There is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there's no training set, this question is not relevant.

Summary

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APR 0 9 20
GC

GC AMERICA INC:
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60803
TEL (708) 597-0900
FAX: (708) 371-5103

1. Submitter Information:

Section 5 - 510(k) Summary

GC AMERICA INC.
3737 W. 127" Street Alsip, IL 60803

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

October 7, 2013 Date Prepared:

2. Device Name:

Proprietary Name:	HTFX-222
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.	MFP-051	K123631	07/23/2013
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: 4.

HTFX-222 is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is a universal type. The material is available in 8 shades: A1, A2, A3, A3.5, A4, A02, AO3 and CV

5. Indications for Use:

1. Liner or base
1. Blocking out undercuts
1. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
1. Sealing hypersensitive areas
1. Fissure sealant
1. Direct restorative for small Class I, II, III, IV, and V cavities
Technological characteristics: 6.

All the components of the applicant device, HTFX-222, have already been used in the predicate devices. 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/22 description: The image contains two distinct logos. The logo on the left is diamond-shaped and contains text, while the logo on the right is circular and also contains text. The text in the diamond-shaped logo is stacked, and the text in the circular logo is arranged in a more compact manner. Both logos appear to be stamps or seals, given their design and layout.

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Page 2

1. 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 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.

Differences

The following differences may be noted between the predicate devices and HTFX-222:

· All products listed under "Performance Test Results" (Table 18) meet ISO 4049 and differences in Depth of Cure, Flexural Strength and Water Sorption are noted.

8. Performance Bench Tests

It is confirmed that the device conforms to the required specifications of ISO 4049:2009 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
Shelf Life Evaluation and Storage Conditions: ರಿ.
- Shelf Life 3 years ।
- Store in a cool and dark place. 4-25℃ (39.2 77.0ºF)

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Device	Comparative device
MFP-051	GC	KALORE(GDLS-200)	PREMISE	Tetric Evoceram	G-aenial Universal Flo(GCUC-505)
		Light-curedradiopaqueuniversalcompositerestorative	Universal nano-filledcomposite	Light-curing, universalnano-hybrid compositematerial for high-endstandard restorations inthe anterior and posteriorregions	UNIVERSALLIGHT-CUREDRADIOPAQUEFLOWABLECOMPOSITE
	GC CorporationK082434	GC CorporationK082434	KERR CORPORATIONK032921	Ivoclar Vivadent. Inc.K042819	GC CorporationK091388
	1. Direct restorative forclass I, II, III, IV, Vcavities.	1. Direct restorative forGDLS is a light-curedmicro-filled radiopaqueresin for the restorationof both anterior andposterior teeth.GDLS-200 consists oftwo delivery systems,Unitip(capsules forsingle dose) andSyringes. TheGDLS-200 system isavailable in a variety ofshades.	Premise is a dentalcomposite restorativematerial intended to beused in all classes ofcavities.	• Anteriorrestorations(ClassIII, IV)• Class V restorations(cervical caries, rooterosion,wedge-shapeddefects)• Restorations in theposterior region(Class I and II)• Veneering ofdiscolored anteriorteeth• Splinting of mobileteeth• Repair of compositeand ceramic veneers	1. Restoration of class I,II, III, IV, V cavities.2. Restoration of rootsurface caries3. Restoration ofdeciduous teeth4. Filling tunnel shapedcavities5. Sealinghypersensitive areas6. Liner/base/filling incavity undercuts7. Sealant8. Splinting mobile teeth9. Additions tocompositerestorations
	2. Direct restorative forwedge-shaped defectsand root surfacecavities.
	3. Direct restorative forveneers and diastemaclosure.

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Image /page/3/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely part of a document or sign.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MI) 20993-0002

April 9, 2014

GC AMERICA INCORPORATED Mark Heiss, D.D.S. 3737 W. 127" Street Alsip, Illinois 60803

Re: K133182

Trade/Device Name: HTFX-222 Regulation Number: 21 CFR 872.3690 Regulation Name: Tooth shade resin material Regulatory Class: II Product Code: EBF Dated: February 24, 2014 Received: March 4, 2014

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 10 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. Wc 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.

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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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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.

http://www.fda.gov/medicaldevices/resourcesforyou/industry/ucm142661.htm

Sincerely yours,

Mary S. Runner -S

Erin I. Keith, M.S. 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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Section 4 - Indications for Use Statement

Indications for Use

510(k) Number (if known):

Device Name: HTFX-222

Indications for Use:

Liner or base
Blocking out undercuts

1. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
1. Sealing hypersensitive areas

Fissure sealant

1. Direct restorative for small Class I, II, III, IV, and V cavities
  Prescription Use _ X (Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Sheena A. Green 2014.04.09 12:09:39 04'00'

Page 4.1 of 4.1

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.