GC FUJI TEMP

K101420 · GC America, Inc. · EMA · Sep 17, 2010 · Dental

Device Facts

• Record ID: K101420
• Device Name: GC FUJI TEMP
• Applicant: GC America, Inc.
• Product Code: EMA · Dental
• Decision Date: Sep 17, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3275
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Temporary cementation of crowns and bridges. Provisional cementation of crowns and bridges on implant abutments.

Device Story

GC Fuji TEMP is a 2-paste glass ionomer provisional luting cement. Components are supplied in separate syringes assembled in a single cartridge; dispensed using a Paste Pak Dispenser to ensure correct ratio. Used by dental professionals in a clinical setting for temporary cementation of crowns and bridges, including those on implant abutments. The material forms an ionic bond with tooth structure and provides radiopacity and fluoride release. The clinician mixes the pastes and applies the cement to the restoration; the material sets to secure the provisional restoration. This allows for temporary fixation of dental prosthetics, facilitating later removal or replacement.

Clinical Evidence

Bench testing only. Performance evaluated against ISO 3107:2004 and ISO 9917-1:2007 standards. Tests included appearance, film thickness (<25µm), setting time (4-10 min), compressive strength (<35MPa), acid-soluble lead content (<100mg/kg), radiopacity, working time (2.5-3.5 min), color, and consistency (27-37 mm). All results met specified requirements.

Technological Characteristics

2-paste glass ionomer luting cement. Paste A: Fluoro-alumino silicate glass, distilled water, viscosity modifiers, pigments. Paste B: Distilled water, polyacrylic acid, radiopacity agent, pH adjuster, viscosity modifiers. Sensing/actuation: Chemical ionic bonding. Form factor: Dual-syringe cartridge for use with Paste Pak Dispenser. Standards: ISO 3107:2004, ISO 9917-1:2007, Company Spec AB-15-Q-301-493.

Indications for Use

Indicated for temporary or provisional cementation of crowns and bridges, including those on implant abutments, in dental patients.

Regulatory Classification

Identification

Zinc oxide-eugenol is a device composed of zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp. Dental cement other than zinc oxide-eugenol is a device composed of various materials other than zinc oxide-eugenol intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Predicate Devices

• Fuji I (K980695)
• Freegenol Temporary Pack (K842994)

Submission Summary (Full Text)

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K101420

GC

SEP 1 7 2010

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

# Section 6 - 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

#### Submitter Information: ﻬﻨ

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

| Contact Person: | Mark Heiss, D.D.S. |
|-----------------|--------------------|
| Phone: | [phone] |
| Fax: | [phone] |

Date Prepared: April 14, 2010

#### 2. Device Name:

| Proprietary Name: | GC Fuji Temp |
|------------------------|--------------------|
| Classification Name: | Dental Cement |
| Device Classification: | Class II, 872.3275 |
| Product Code: | EMA |

- Predicate Devices: 3.

| Company | Device | 510(k) No. | Date<br>Cleared |
|-----------------|--------------------------|------------|-----------------|
| GC America Inc. | Fuji I | K980695 | 4/13/98 |
| GC America Inc. | Freegenol Temporary Pack | K842994 | 10/18/84 |

### Description of Device: 4.

,

GC Fuji TEMP is a 2-paste type, glass ionomer provisional luting cement filled in separate syringes, and assembled in one cartridge. With use of Paste Pak Dispenser, GC Fuji TEMP can be dispensed with the appropriate paste ratio.

The applicant device, GC Fuji TEMP is substantially equivalent to the predicate devices in its intended use. Fuii I is intended for final cementation. Freegenol Temporary Pack is intended for temporary cementation. Although the intended periods in oral are different, all devices are used as luting cements.

#### 5. Indications for Use:

- · Temporary cementation of crowns and bridges
- · Provisional cementation of crowns and bridges on implant abutments
- Technological characteristics: ్.

GC Fuji TEMP is a 2-paste type, glass ionomer provisional luting cement filled in separate syringes, and assembled in one cartridge. With use of Paste Pak Dispenser, GC Fuji TEMP can be dispensed with the appropriate paste ratio.

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GC Fuji TEMP Paste A contains Fluoro-alumino silicate glass (Forming ionic bond with polyacylic acid, and provides radiopacity and fluoride release), distilled water, viscosity modifying agents, anti-septic and pigments. Paste B contains distilled water, Polyacrylic acid (Forming ionic bond with fluoroalumino-silicate glass and calcium contained in tooth structure), radiopacity agent, pH adjusting agent, and viscosity modifying agents.

#### 7. Summary of Physical tests:

ﻟﺘﻲ ﺗﻌﺘﺒﺮ ﺍﻟﻤﺪﻳﻨﺔ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤ

## List of Standards used/results

*ISO 3107: 2004 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements * ISO 9917-1: 2007 Dentistry - Water-based cements - Part 1: Powder/liquid acid-base coments * Company Specification: AB-15-Q-301-493

| | Property | Standards | Test methods | Requirements | Result-<br>qualitative |
|---|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------|
| 1 | Appearance | ISO 9917-1: 2007 5<br>Material | Visually inspected<br>before and after paste<br>mixing | • Free from<br>extraneous<br>material<br>• Homogeneous<br>and smoothly<br>consistent | Within spec<br>set by<br>standard |
| 2 | Film<br>thickness | ISO 3107: 2004<br>Dentistry - Zinc<br>oxide/eugenol and<br>zinc oxide/non-<br>eugenol cements,<br>Section 6.4<br>Determination of film<br>thickness | (150 (+/-) 2) N load is<br>applied for 10 min, 90<br>sec after start of mix<br>(N=5) | Less than 25µm | Within spec<br>set by<br>standard |
| 3 | Setting time | ISO 3107: 2004<br>Dentistry - Zinc<br>oxide/eugenol and<br>zinc oxide/non-<br>eugenol cements,<br>Section 6.2<br>Determination of<br>setting time | Mixed cement is<br>placed at 37 deg, 180<br>sec after end of mix.<br>The time when<br>needle fails to<br>penetrate completely<br>2mm depth of cement<br>is defined, counting<br>from start of mix.<br>(N=2) | 4 to 10 min | Within spec<br>set by<br>standard |
| 4 | Compressive<br>strength | ISO 3107: 2004<br>Dentistry - Zinc<br>oxide/eugenol and<br>zinc oxide/non-<br>eugenol cements,<br>Section 6.3<br>Determination of<br>compressive strength | Specimens (6mm<br>high, 4mm in<br>diameter)<br>compressed at<br>1mm/min (N=5) | Less than 35MPa | Within spec<br>set by<br>standard |
| 5 | Acid-soluble<br>lead content | ISO 9917-1: 2007<br>Dentistry - Water-<br>based cements -- Part<br>1: Powder/liquid,<br>Section 13.2 Acid-<br>soluble lead content | Soaked in lactic acid<br>solution (pH 2.74) for<br>24 hours. (N=5) | Less than 0.40mm | Within spec<br>set by<br>standard |

Table 8.1.1 Test standards and methods based on ISO standards

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| 6 | Acid-soluble<br>lead content | ISO 9917-1: 2007<br>Dentistry - Water-<br>based cements - Part<br>1: Powder/liquid,<br>Section 13.2 Acid-<br>soluble lead content | Crushed cement after<br>setting is soaked in<br>diluted HCI solution<br>for 16 hours. Eluted<br>lead is detected by<br>atomic absorption or<br>equivalent method.<br>(N=1) | Less than<br>100mg/kg | Within spec<br>set by<br>standard |
|---|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------|
| 7 | Radiopacity | ISO 9917-1: 2007<br>Dentistry - Water-<br>based cements - Part<br>1: Powder/liquid,<br>Section 14<br>Radiopacity | Compared to<br>aluminum (N=1) | More than<br>equivalent<br>thickness of<br>aluminum | Within spec<br>set by<br>standard |

*ISO 3107:2004 is referred in consideration of clinical use of GC Fuji TEMP, which is relatively used for temporary, although the formulation of GC Fuji TEMP doesn't belong to zinc oxide/eugenol or zinc oxide/non-eugenol coments.

*ISQ 9917-1: 2007 is referred in consideration of the formulation of GC Fuji TEMP, which is based on glass polyalkenoate. In that requirement, acid erosion for glass polyalkenoate coments is "Max. 0.17 mm". However, in view of provisional cementation, the criteria for zinc polycarboxylate cements are adopted.

| | Property | Standards and<br>test methods<br>applied | Test method | Requirements | |
|---|-----------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------|
| 1 | Working<br>time | Company<br>Specification: AB-<br>15-Q-301-493 | The time when mixed<br>cement becomes rubbery<br>is defined as working<br>time (from start of mix). | 2min30sec -<br>3min30sec<br>(given by the<br>manufacturer) | Within spec set<br>by standard |
| 2 | Color | Company<br>Specification: AB-<br>15-Q-301-493 | Comparing set cement<br>with standard sample | Equivalent to<br>standard sample | Within spec set<br>by standard |
| 3 | Consistency | Company<br>Specification AB-<br>15-Q-301-493 | 0.5 mL of mixed cement<br>is Loaded with 120g for<br>10 minutes. Average of<br>long axis and short axis<br>are calculated. | 27 – 37 mm<br>(given by the<br>manufacturer) | Within spec set<br>by standard |

## Description of Safety and Substantial Equivalence: ----- 8.

All the components of the applicant device, GC Fuji Temp, have already been used in the predicate devices which are legally marked for the same indications and the same type of tissue contact. This supports the compatibility of GC Fuji Temp and the safety of the applicant device is substantially equivalent to the predicate devices. The new device and predicate devices are similar in function, composition, and intended use.

------

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Image /page/3/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle are three stylized human figures, stacked on top of each other.

# DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Mr. Mark Heiss Director, New Business Development, Academic & Regulatory Affairs GC America, Incorporated 3737 West 127th Street Alsip, Illinois 60803

... •

Re: K101420

SEP 1 7 2010

Trade/Device Name: GC Fuji Temp Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA Dated: August 24, 2010 Received: August 25, 2010

Dear Mr. 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.

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Page 2- Mr. 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 (QS) 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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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.

Sincerely yours,

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 5

Indications for Use

SEP 1 7 2010

510(k) Number (if known):

GC Fuji TEMP Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

- Temporary cementation of crowns and bridges ●
- Provisional cementation of crowns and bridges on implant abutments ●

Prescription Use X (Part 21 CFR 801 Subpart D)

- 1.

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Susan Runner

(Division Sign-Off) (Division Sign-Off)
Division of Anestheslology, General Hospital
Division of Anestheslology, General Devices Division of Anesthesionogy .
Infection Control, Dental Devices KIDIYAD

510(k) Number: ر

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