HTFX-222

K133182 · GC America, Inc. · EBF · Apr 9, 2014 · Dental

Device Facts

• Record ID: K133182
• Device Name: HTFX-222
• Applicant: GC America, Inc.
• Product Code: EBF · Dental
• Decision Date: Apr 9, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3690
• Device Class: Class 2
• Attributes: Therapeutic

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

Device Story

HTFX-222 is a light-cured, nano-filled, radiopaque composite resin supplied in a syringe. Used by dental professionals in clinical settings for restorative dentistry. Principle of operation involves polymerization of methacrylate ester monomers via a photo-initiator system upon exposure to a curing light. Applied directly to tooth structures or existing restorations to fill cavities, seal areas, or repair defects. Output is a hardened, tooth-colored restorative material. Benefits include aesthetic restoration of tooth structure and protection of hypersensitive areas. Clinical decision-making relies on the practitioner's assessment of cavity class and restoration needs.

Clinical Evidence

Bench testing only. Device performance evaluated against ISO 4049:2009 standards. Tests included depth of cure, flexural strength, water sorption, solubility, color stability, and radiopacity. Results confirmed the device meets required specifications and is suitable for its intended use.

Technological Characteristics

Light-cured, nano-filled, radiopaque composite resin. Polymerization via photo-initiator system. Complies with ISO 4049:2009. Available in 8 shades. Storage: 4-25°C.

Indications for Use

Indicated for use as a liner, base, fissure sealant, for blocking out undercuts, sealing hypersensitive areas, repairing aesthetic restorations (composites, veneers, crowns, bridges), and as a direct restorative for small Class I-V cavities.

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

• MFP-051 (K123631)
• GC KALORE (GDLS-200) (K082434)
• G-aenial Universal Flo (GCUC-505) (K091388)
• PREMISE (K032921)
• Tetric Evoceram (K042819)

Submission Summary (Full Text)

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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.

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### Page 2

- 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<br>(GCUC-505) |
| | | Light-cured<br>radiopaque<br>universal<br>composite<br>restorative | Universal nano-filled<br>composite | Light-curing, universal<br>nano-hybrid composite<br>material for high-end<br>standard restorations in<br>the anterior and posterior<br>regions | UNIVERSAL<br>LIGHT-CURED<br>RADIOPAQUE<br>FLOWABLE<br>COMPOSITE |
| | GC Corporation<br>K082434 | GC Corporation<br>K082434 | KERR CORPORATION<br>K032921 | Ivoclar Vivadent. Inc.<br>K042819 | GC Corporation<br>K091388 |
| | 1. Direct restorative for<br>class I, II, III, IV, V<br>cavities. | 1. Direct restorative for<br>GDLS is a light-cured<br>micro-filled radiopaque<br>resin for the restoration<br>of both anterior and<br>posterior teeth.<br>GDLS-200 consists of<br>two delivery systems,<br>Unitip(capsules for<br>single dose) and<br>Syringes. The<br>GDLS-200 system is<br>available in a variety of<br>shades. | Premise is a dental<br>composite restorative<br>material intended to be<br>used in all classes of<br>cavities. | • Anterior<br>restorations(Class<br>III, IV)<br>• Class V restorations<br>(cervical caries, root<br>erosion,<br>wedge-shaped<br>defects)<br>• Restorations in the<br>posterior region<br>(Class I and II)<br>• Veneering of<br>discolored anterior<br>teeth<br>• Splinting of mobile<br>teeth<br>• Repair of composite<br>and ceramic veneers | 1. Restoration of class I,<br>II, III, IV, V cavities.<br>2. Restoration of root<br>surface caries<br>3. Restoration of<br>deciduous teeth<br>4. Filling tunnel shaped<br>cavities<br>5. Sealing<br>hypersensitive areas<br>6. Liner/base/filling in<br>cavity undercuts<br>7. Sealant<br>8. Splinting mobile teeth<br>9. Additions to<br>composite<br>restorations |
| | 2. Direct restorative for<br>wedge-shaped defects<br>and root surface<br>cavities. | | | | |
| | 3. Direct restorative for<br>veneers and diastema<br>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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