HTFX-222

• K Number: K133182
• Device Name: HTFX-222
• Manufacturer: GC AMERICA, INC.
• Date Cleared: 2014-04-09 ( 174 days)
• Product Code: EBF
• Regulation Number: 872.3690

Intended Use

1. Liner or base 2. Blocking out undercuts 3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. 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

Predicate Devices

K123631, K082434, K091388, K032921, K042819

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

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

Therapeutic

No
The Indications for Use describe reparative and restorative dental procedures, not therapeutic ones according to the common definition of therapeutic devices.

Diagnostic

No

The device is a composite resin used for restorative dental procedures, not for diagnosing conditions. Its intended uses include filling cavities, repairing restorations, and sealing hypersensitive areas, which are all treatment functions.

SaMD (Software as a Medical Device)

No

The device description clearly states it is a "light cured nano-filled radiopaque composite resin filled in a syringe," which is a physical material, not software. The performance studies also focus on material properties.

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 the patient's teeth (liner, base, blocking undercuts, repairing restorations, sealing hypersensitive areas, filling cavities). These are clinical procedures, not tests performed on samples taken from the body in vitro (outside the body).
• Device Description: The device is a light-cured composite resin, a material used for dental restorations. This is consistent with a device used directly in the mouth.
• Performance Studies: The performance studies listed (sensitivity to ambient light, depth of cure, flexural strength, water sorption, solubility, color stability, radiopacity) are all related to the physical and chemical properties of the material and its performance in situ (in the mouth), not its ability to diagnose a condition from a sample.
• Anatomical Site: The anatomical site is "Teeth," which are part of the patient's body, not a sample taken from the body.

IVD devices are typically used to examine specimens such as blood, urine, tissue, etc., to provide information for the diagnosis, monitoring, or treatment of a disease or condition. 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
• 2. Blocking out undercuts
• 3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
• 4. Sealing hypersensitive areas
• 5. Fissure sealant
• 6. Direct restorative for small Class I, II, III, IV, and V cavities

Product codes

EBF

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

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 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

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

Not Found

Predicate Device(s)

K123631, 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

APR 0 9 20
GC

GC AMERICA INC:
3737 WEST 127TH STREET
ALSIP, ILLINOIS 60803
TEL [phone]
FAX: [phone]

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:	[phone]
Fax:	[phone]

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
• 2. Blocking out undercuts
• 3. Repair of direct and indirect aesthetic restorations: composites, veneers, crowns and bridges (including temporary crowns and bridges), defect margins when margins are in enamel
• 4. Sealing hypersensitive areas
• 5. Fissure sealant
• 6. 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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• 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 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-cured
radiopaque
universal
composite
restorative	Universal nano-filled
composite	Light-curing, universal
nano-hybrid composite
material for high-end
standard restorations in
the anterior and posterior
regions	UNIVERSAL
LIGHT-CURED
RADIOPAQUE
FLOWABLE
COMPOSITE
	GC Corporation
K082434	GC Corporation
K082434	KERR CORPORATION
K032921	Ivoclar Vivadent. Inc.
K042819	GC Corporation
K091388
	1. Direct restorative for
class I, II, III, IV, V
cavities.	1. Direct restorative for
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 I and II)
• Veneering of
discolored anterior
teeth
• Splinting of mobile
teeth
• Repair of composite
and ceramic veneers	1. Restoration of class I,
II, III, IV, V cavities.

2. Restoration of root
   surface caries
3. Restoration of
   deciduous teeth
4. Filling tunnel shaped
   cavities
5. Sealing
   hypersensitive areas
6. Liner/base/filling in
   cavity undercuts
7. Sealant
8. Splinting mobile teeth
9. Additions to
   composite
   restorations |
   | | 2. Direct restorative for
   wedge-shaped defects
   and root surface
   cavities. | | | | |
   | | 3. Direct restorative for
   veneers and diastema
   closure. | | | | |

:

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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 [phone] or [phone] 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 [phone] or [phone] 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:

1. Liner or base

2. Blocking out undercuts

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

5. Fissure sealant

• 6. 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'

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