(120 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of a dental cement, with no mention of AI or ML.
No
This device is a temporary luting cement used for provisional cementation of crowns and bridges, not a therapeutic device.
No
The device is a temporary luting cement for crowns and bridges, which is a therapeutic or restorative function, not a diagnostic one.
No
The device description clearly states it is a 2-paste type, glass ionomer provisional luting cement, which is a physical material, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "Temporary cementation of crowns and bridges" and "Provisional cementation of crowns and bridges on implant abutments." This describes a material used in the mouth for a dental procedure, not a test performed outside the body on biological samples to diagnose a condition.
- Device Description: The description details a "provisional luting cement" which is a material used to bond dental restorations. This aligns with a dental material, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
Therefore, GC Fuji TEMP is a dental material used for temporary cementation, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
- Temporary cementation of crowns and bridges
- Provisional cementation of crowns and bridges on implant abutments
Product codes
EMA
Device Description
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.
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.
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)
Summary of Physical tests:
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: Appearance
Standards: ISO 9917-1: 2007 5 Material
Test methods: Visually inspected before and after paste mixing
Requirements: • Free from extraneous material • Homogeneous and smoothly consistent
Result: Within spec set by standard -
Property: Film thickness
Standards: ISO 3107: 2004 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements, Section 6.4 Determination of film thickness
Test methods: (150 (+/-) 2) N load is applied for 10 min, 90 sec after start of mix (N=5)
Requirements: Less than 25µm
Result: Within spec set by standard -
Property: Setting time
Standards: ISO 3107: 2004 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements, Section 6.2 Determination of setting time
Test methods: Mixed cement is placed at 37 deg, 180 sec after end of mix. The time when needle fails to penetrate completely 2mm depth of cement is defined, counting from start of mix. (N=2)
Requirements: 4 to 10 min
Result: Within spec set by standard -
Property: Compressive strength
Standards: ISO 3107: 2004 Dentistry - Zinc oxide/eugenol and zinc oxide/non-eugenol cements, Section 6.3 Determination of compressive strength
Test methods: Specimens (6mm high, 4mm in diameter) compressed at 1mm/min (N=5)
Requirements: Less than 35MPa
Result: Within spec set by standard -
Property: Acid-soluble lead content
Standards: ISO 9917-1: 2007 Dentistry - Water-based cements -- Part 1: Powder/liquid, Section 13.2 Acid-soluble lead content
Test methods: Soaked in lactic acid solution (pH 2.74) for 24 hours. (N=5)
Requirements: Less than 0.40mm
Result: Within spec set by standard -
Property: Acid-soluble lead content
Standards: ISO 9917-1: 2007 Dentistry - Water-based cements - Part 1: Powder/liquid, Section 13.2 Acid-soluble lead content
Test methods: Crushed cement after setting is soaked in diluted HCI solution for 16 hours. Eluted lead is detected by atomic absorption or equivalent method. (N=1)
Requirements: Less than 100mg/kg
Result: Within spec set by standard -
Property: Radiopacity
Standards: ISO 9917-1: 2007 Dentistry - Water-based cements - Part 1: Powder/liquid, Section 14 Radiopacity
Test methods: Compared to aluminum (N=1)
Requirements: More than equivalent thickness of aluminum
Result: Within spec set by 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: Working time
Standards: Company Specification: AB-15-Q-301-493
Test method: The time when mixed cement becomes rubbery is defined as working time (from start of mix).
Requirements: 2min30sec - 3min30sec (given by the manufacturer)
Results: Within spec set by standard -
Property: Color
Standards: Company Specification: AB-15-Q-301-493
Test method: Comparing set cement with standard sample
Requirements: Equivalent to standard sample
Results: Within spec set by standard -
Property: Consistency
Standards: Company Specification AB-15-Q-301-493
Test method: 0.5 mL of mixed cement is Loaded with 120g for 10 minutes. Average of long axis and short axis are calculated.
Requirements: 27 – 37 mm (given by the manufacturer)
Results: Within spec set by standard
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.3275 Dental cement.
(a)
Zinc oxide-eugenol —(1)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.(2)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 872.9.(b)
Dental cement other than zinc oxide-eugenol —(1)Identification. 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.(2)
Classification. Class II.
0
GC
SEP 1 7 2010
GC AMERICA INC. 3737 WEST 127TH STREET ALSIP, ILLINOIS 60803 TEL (708) 597-0900 FAX (708) 371-5103
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: | (708) 897-4042 |
| Fax: | (708) 897-4031 |
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
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.
1
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-
qualitative |
|---|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------|
| 1 | Appearance | ISO 9917-1: 2007 5
Material | Visually inspected
before and after paste
mixing | • Free from
extraneous
material
• Homogeneous
and smoothly
consistent | Within spec
set by
standard |
| 2 | Film
thickness | ISO 3107: 2004
Dentistry - Zinc
oxide/eugenol and
zinc oxide/non-
eugenol cements,
Section 6.4
Determination of film
thickness | (150 (+/-) 2) N load is
applied for 10 min, 90
sec after start of mix
(N=5) | Less than 25µm | Within spec
set by
standard |
| 3 | Setting time | ISO 3107: 2004
Dentistry - Zinc
oxide/eugenol and
zinc oxide/non-
eugenol cements,
Section 6.2
Determination of
setting time | Mixed cement is
placed at 37 deg, 180
sec after end of mix.
The time when
needle fails to
penetrate completely
2mm depth of cement
is defined, counting
from start of mix.
(N=2) | 4 to 10 min | Within spec
set by
standard |
| 4 | Compressive
strength | ISO 3107: 2004
Dentistry - Zinc
oxide/eugenol and
zinc oxide/non-
eugenol cements,
Section 6.3
Determination of
compressive strength | Specimens (6mm
high, 4mm in
diameter)
compressed at
1mm/min (N=5) | Less than 35MPa | Within spec
set by
standard |
| 5 | Acid-soluble
lead content | ISO 9917-1: 2007
Dentistry - Water-
based cements -- Part
1: Powder/liquid,
Section 13.2 Acid-
soluble lead content | Soaked in lactic acid
solution (pH 2.74) for
24 hours. (N=5) | Less than 0.40mm | Within spec
set by
standard |
Table 8.1.1 Test standards and methods based on ISO standards
2
| 6 | Acid-soluble
lead content | ISO 9917-1: 2007
Dentistry - Water-
based cements - Part
1: Powder/liquid,
Section 13.2 Acid-
soluble lead content | Crushed cement after
setting is soaked in
diluted HCI solution
for 16 hours. Eluted
lead is detected by
atomic absorption or
equivalent method.
(N=1) | Less than
100mg/kg | Within spec
set by
standard |
|---|------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|-----------------------------------|
| 7 | Radiopacity | ISO 9917-1: 2007
Dentistry - Water-
based cements - Part
1: Powder/liquid,
Section 14
Radiopacity | Compared to
aluminum (N=1) | More than
equivalent
thickness of
aluminum | Within spec
set by
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
test methods
applied | Test method | Requirements | |
|---|-----------------|-----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------|--------------------------------|
| 1 | Working
time | Company
Specification: AB-
15-Q-301-493 | The time when mixed
cement becomes rubbery
is defined as working
time (from start of mix). | 2min30sec -
3min30sec
(given by the
manufacturer) | Within spec set
by standard |
| 2 | Color | Company
Specification: AB-
15-Q-301-493 | Comparing set cement
with standard sample | Equivalent to
standard sample | Within spec set
by standard |
| 3 | Consistency | Company
Specification AB-
15-Q-301-493 | 0.5 mL of mixed cement
is Loaded with 120g for
10 minutes. Average of
long axis and short axis
are calculated. | 27 – 37 mm
(given by the
manufacturer) | Within spec set
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.
3
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.
4
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 (800) 638-2041 or (301) 796-7100 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
5
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)
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
Page 5.1 of 5.1