1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
1. Cementation of metal, ceramic, fiber posts, and cast post and cores.
1. Cementation of all ceramic and composite veneers (up to 2 teeth)
1. Permanent cementation of crowns and bridges on implant abutments.

GC DUAL CURE ACTIVATOR

Cementation of indirect restorations.
Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.

TRY-IN PASTE
To evaluate the shade and the fitting of the restoration prior to permanent cementation.

MULTI PRIMER

1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
1. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.

Device Description

GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used with G-Premio BOND (510(k) No. K143140).

TRY-IN PASTE is a hue-conformity verification material. The product is placed into a dental restoration and set on an abutment tooth to verify hue and conformity. The product has a same color as G-CEM LinkForce.

MULTI PRIMER is a priming agent designed to treat the adherend surface of glass ceramic, oxide ceramic, hybrid ceramic, composite and metal restorations to promote a strong bond to resin-based materials as resin-based cements in case of luting procedures or direct composites in case of repairs.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the G-Cem LinkForce, GC Dual Cure Activator, Try-In Paste, and Multi Primer devices, based on the provided text.

Note: The provided document is a 510(k) premarket notification and primarily focuses on demonstrating substantial equivalence to predicate devices rather than reporting on a standalone clinical study for the new device. Therefore, much of the requested information regarding detailed clinical study design (sample size, ground truth, experts, MRMC studies, training set details) is not present. The studies mentioned are primarily in vitro performance bench tests against ISO standards.

1. Acceptance Criteria and Reported Device Performance

The acceptance criteria are primarily defined by ISO standards and internal company specifications. The document states that the applicant device conforms to these required specifications.

Table of Acceptance Criteria and Reported Device Performance (Summary from Tables 5.2, 5.3, 5.4, 5.5)

Device Group	Property	Standard / Test Method	Acceptance Criteria (Requirements)	Reported Device Performance (Implied)
G-CEM LinkForce	Film thickness	ISO 4049: 2009 5.2.2	No greater than 50 µm	Meets criteria (implied)
	Working time	ISO 4049: 2009 5.2.4	No detectable change in its homogeneity	Meets criteria (implied)
	Setting time	ISO 4049: 2009 5.2.6	Not more than 10 min	Meets criteria (implied)
	Depth of cure (Opaque shade)	ISO 4049: 2009 5.2.8	Not less than 0.5 mm	Meets criteria (implied)
	Depth of cure (Other shade)	ISO 4049: 2009 5.2.8	Not less than 1.5 mm	Meets criteria (implied)
	Flexural strength	ISO 4049: 2009 5.2.9	Greater than 50 MPa	Meets criteria (implied)
	Water sorption	ISO 4049: 2009 5.2.10	Less than 40 µg/mm	Meets criteria (implied)
	Solubility	ISO 4049: 2009 5.2.10	Less than 7.5 µg/mm	Meets criteria (implied)
	Radiopacity	ISO 4049: 2009 5.5	Greater than the same thickness of aluminum	Meets criteria (implied)
GC DUAL CURE ACTIVATOR (with G-Premio BOND)	Adhesion to Bovine Dentin	ISO 11405: 2015 5.1.4 (Shear bond strength)	Greater than 5MPa	Meets criteria (implied)
	Adhesion to Bovine Enamel	ISO 11405: 2015 5.1.4 (Shear bond strength)	Greater than 9MPa	Meets criteria (implied)
TRY-IN PASTE	Film thickness	Company Specification	No greater than 50 µm	Meets criteria (implied)
MULTI PRIMER	Tensile bond strength to Porcelain	Company Specification	Greater than 10MPa	Meets criteria (implied)
	Tensile bond strength to Zirconia	Company Specification	Greater than 10MPa	Meets criteria (implied)
	Tensile bond strength to Au-Ag-Pd alloy	Company Specification	Greater than 10MPa	Meets criteria (implied)

Biocompatibility for all devices (G-CEM LinkForce, GC DUAL CURE ACTIVATOR, TRY-IN PASTE, MULTI PRIMER):

Cytotoxicity (ISO 10993-5): No cytotoxic effect.
Sensitization (ISO 10993-10): 0% sensitization rate, non-irritant to buccal tissues.

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

The document describes performance bench tests according to ISO standards, not a clinical test set with human subjects.

Sample Size: Not explicitly stated for each specific test, but ISO standards typically involve a defined number of specimens for mechanical and physical property testing.
Data Provenance: In-vitro laboratory testing, likely conducted by the manufacturer, GC America Inc. Country of origin not specified, but the submission is to the US FDA. The data is retrospective in the sense that it's reported on already conducted tests.

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

Not applicable. The ground truth for performance bench tests is the objective measurement of physical and mechanical properties against pre-defined engineering and material standards (ISO standards, company specifications). There's no "expert ground truth consensus" involved in this type of testing.

4. Adjudication Method for the Test Set

Not applicable. This type of performance testing involves direct physical measurements, not interpretation or adjudication by experts.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This submission is for dental cements and primers, which are materials, not AI-powered diagnostic or assistive devices that would involve human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. These are physical dental materials, not algorithms.

7. The Type of Ground Truth Used

The ground truth used for these performance bench tests are:

Established ISO standards for dental materials (ISO 4049:2009, ISO 11405:2015, ISO 10993-5, ISO 10993-10). These standards define the methodology and acceptable ranges for various physical, mechanical, and biological properties.
Company Specifications for properties like film thickness (Try-in Paste) and tensile bond strength to various restorative materials (Multi Primer).

8. The Sample Size for the Training Set

Not applicable. These are dental materials tested against standards, not AI algorithms requiring a training set.

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

Not applicable, as there is no training set for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles facing right, suggesting a focus on people and health.

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

July 6, 2016

GC America, Inc. Mark Heiss. D.D.S. Director, Academic & Regulatory Affairs 3737 W. 127th St. Alsip, Illinois 60803

Re: K153231

Trade/Device Name: G-Cem LinkForce, GC Dual Cure Activator, Try-in Paste, Multi Primer Regulation Number: 21 CFR 872.3275 Regulation Name: Dental Cement Regulatory Class: II Product Code: EMA, KLE, EBF Dated: May 25, 2016 Received: May 27, 2016

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 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 - Mark Heiss, D.D.S.

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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Tina
Kiang -S

for Erin I. Keith, M.S. 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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510(k) Number : K153231 Device Name: G-Cem LinkForce Indications for Use:

G-Cem LinkForce

1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
1. Cementation of metal, ceramic, fiber posts, and cast post and cores.
1. Cementation of all ceramic and composite veneers (up to 2 teeth)
1. Permanent cementation of crowns and bridges on implant abutments.

Prescription Use _ _ X

AND/OR

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

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

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

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510(k) Number: K153231 Device Name: GC DUAL CURE ACTIVATOR Indications for Use:

GC DUAL CURE ACTIVATOR

Cementation of indirect restorations.
Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.

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

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510(k) Number: K153231

Device Name: TRY-IN PASTE -

Indications for Use:

TRY-IN PASTE

To evaluate the shade and the fitting of the restoration prior to permanent cementation.

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)

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510(k) Number : K153231 Device Name: MULTI PRIMER Indications for Use:

MULTI PRIMER

1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
1. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)

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Image /page/6/Picture/1 description: The image shows the green text "'GC'" on a white background. The letters are bold and slightly italicized. The single quotation marks are placed before and after the letters.

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

Submitter Information: 1.
GC AMERICA INC. 3737 W. 127th Street Alsip, IL 60803

Contact Person:	Mark Heiss, D.D.S
Phone:	(708) 926-3090
Alternate Contact:	Lori Rietman
Phone:	(708) 926-3092
Fax:	(708) 926-9100

Date Prepared: May 25, 2016

Device Name: 2.
G-Cem LinkForce, GC Dual Cure Activator, Try-In Paste and Multi Primer Proprietary Name: Classification Name: Dental Cement Device Classification: Class II, 872.3275 Product Code: EMA, KLE, EBF 510(k) Number: K153231

3. Predicate Devices:

Applicant Product	Product Type	Predicate Device	510(k) No.	Product Code	Predicate
G-CEM LinkForce	Cement	RelyX Ultimate	K110508	EMA	Primary
		LINKMAX	K001823	EMA	Reference
GC Dual Cure Activator	Dual Cure Activator	Scotchbond Universal	K110302	KLE	Primary
		LINKMAX Self Etching PrimerA and Primer B	K001823	EMA	Reference
Try-In Paste	Try-In Paste	Variolink Veneer Try-In	K931309	EBF	Primary
		RelyX Try-In Paste	K002452	EMA	Reference
Multi Primer	Primer	Ceramic Primer II	K001823	EMA	Primary
		Metal Primer II	K972594	KLE	Reference

4. Description of Device:

G-CEM LinkForce

GC DUAL CURE ACTIVATOR

GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used with G-Premio BOND (510(k) No. K143140).

TRY-IN PASTE

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MULTI PRIMER

న్. Indications for Use:

G-CEM LinkForce

1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges.
1. Cementation of metal, ceramic, fiber posts, and cast post and cores.
1. Cementation of all ceramic and composite veneers (up to 2 teeth)
Permanent cementation of crowns and bridges on implant abutments. 4.

GC DUAL CURE ACTIVATOR

1. Cementation of indirect restorations.
1. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure.
1. Bonding of resin cements and core build-up materials and self-cure composites to tooth structure.

TRY-IN PASTE

To evaluate the shade and the fitting of the restoration prior to permanent cementation.

MULTI PRIMER

1. Priming of the adherend surfaces of indirect restorations made of glass ceramics, oxide ceramics, hybrid ceramics, composite and metal before luting procedures.
1. Intra-oral and extra-oral repair of fractured indirect restorations made of ceramics, hybrid ceramics and composites.

6. Technological characteristics:

G-CEM LinkForce

G-CEM LinkForce is a dual-cured resin cement for indirect restorations, which is same as the primary and reference predicate devices. The curing mechanism of the predicate devices and applicant device is polymerization of uncured methacrylate ester monomers. This reaction is caused by photo initiator and chemical polymerization initiator systems.

GC DUAL CURE ACTIVATOR

All the components of the applicant device, GC DUAL CURE ACTIVATOR, have already been used in the reference predicate device. The bonding mechanism of the primary predicate device is applying it to tooth structure, then bonding chemically by polymerization of uncured methacrylate ester monomers. This is the chemical component to initiate and complete chemical cure of G-Premio Bond. The chemical composition of the applicant device is such that it can also bond to tooth surfaces (like the predicate) as well as composites, hybrid ceramics, and metals.

TRY-IN PASTE

TRY-IN PASTE is a hue-conformity verification material consisting of glycerol. The product is placed into a dental restoration and set on an abutment tooth to verify hue and conformity. The product has a same color as G-CEM LinkForce.TRY-IN PASTE is substantially equivalent to the predicate devices in that they are same in function and indications. Furthermore, the applicant device and primary predicate are both glycerol-based in composition.

{8}------------------------------------------------

MULTI PRIMER

Components in MULTI PRIMER have been used in primary predicate device CERAMIC PRIMER II and reference predicate METAL PRIMER II. The bonding mechanism of the applicant device is applying it to indirect restorations, then bonding chemically and mechanically by polymerization of uncured methacrylate ester monomers. This allows an active surface for the cement to bond to the primer.

1. Shelf Life Evaluation and Storage Conditions:

G-CEM LinkForce

Shelf life: 2 years from date of manufacture l
-Recommended for optimal performance, store in refrigerator (2-8°C / 35.6-46.4°F).

MULTI PRIMER

Shelf life: 2 years from date of manufacture -
Recommended for optimal performance, store at room temperature (4-25°C / 39.2-77.0°F). -GC DUAL CURE ACTIVATOR
Shelf life: 2 years from date of manufacture -
Recommended for optimal performance, store at room temperature (4-25°C / 39.2-77.0°F). TRY-IN PASTE
Shelf life: 2 years from date of manufacture l
Recommended for optimal performance, store at room temperature (4-25°C / 39.2-77.0°F). -

8. Performance Bench Tests

It is confirmed that the applicant device conforms to the required specifications and is suitable for its intended use.

List of Standards used:

1. ISO 4049: 2009 Dentistry Polymer-based restorative materials For testing of G-CEM LinkForce
1. ISO11405: 2015 Dental materials Testing of adhesion to tooth structure For testing of G-Premio BOND with GC DUAL CURE ACTIVATOR

Performance testing includes the following:

Standard	ISO 4049: 2009	ISO 11405: 2015
Property	- Appearance- Film thickness- Working time- Setting time- Depth of cure- Flexural strength- Water sorption- solubility- Radiopacity	- Adhesion to Dentin- Adhesion to Enamel

Table 5.1 Performance testing properties

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Table 5.2 Test standards and methods based on ISO 4049: 2009
	Property	Standards	Requirements
1	Film thickness	ISO 4049: 2009 5.2.2 Film thickness of luting materials	No greater than 50 µm
2	Working time	ISO 4049: 2009 5.2.4 Working time, Class 1 and 3 luting materials	No detectable change in its homogeneity
3	Setting time	ISO 4049: 2009 5.2.6 Setting time, Class 3 materials	Not more than 10 min
4	Depth of cure	ISO 4049: 2009 5.2.8 Depth of cure	Opaque shade: not less than 0.5 mmOther shade: not less than 1.5 mm
5	Flexural strength	ISO 4049: 2009 5.2.9 Flexural strength	Greater than 50 MPa
6	Water sorption	ISO 4049: 2009 5.2.10 Water sorption and solubility	Less than 40 µg/mm
7	Solubility	ISO 4049: 2009 5.2.10 Water sorption and solubility	Less than 7.5 µg/mm
8	Radiopacity	ISO 4049: 2009 5.5 Radiopacity	Greater than the same thickness of aluminum

Table 5 2 Test standards and methods based on ISO 4049- 2009

			Table 5.3 Test standards and methods based on ISO 11405: 2015

	Property	Standards	Requirements
1	Tensile bond strength to bovine dentin	ISO 11405: 2015 5.1.4 Shear bond strength	Greater than 5MPa
2	Tensile bond strength to bovine enamel	ISO 11405: 2015 5.1.4 Shear bond strength	Greater than 9MPa

9. Internal Company Test Method:

TRY-IN PASTE and MULTI PRIMER were tested in accordance with company specification test methods.

	Table 5.4 Test methods based on Company Specification
--	-------------------------------------------------------	--	--

	Property	Test method	Requirements
1	Film thickness	Company Specification	No greater than 50 µm

Table 5.5 Test methods based on Company Specification

	Property	Test method	Requirements
1	Tensile bond strength to porcelain	Company Specification	Greater than 10MPa
2	Tensile bond strength to zirconia	Company Specification	Greater than 10MPa
3	Tensile bond strength to Au-Ag-Pd alloy	Company Specification	Greater than 10MPa

10. Biocompatibility

G-CEM LinkForce

G-CEM LinkForce is a dual-cured resin cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. G-CEM LinkForce does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours. Biological testing results in accordance with ISO 10993-5 show the test article does not have a cytotoxic effect. Testing in accordance with ISO 10993-10, showed 0% sensitization rate, and was considered to be non-irritants to the buccal tissues. Biological testing as well as the similarity of components to the predicate device, the similarity of the principle operation, and the similarity of the performance data, support substantial equivalence.

{10}------------------------------------------------

GC DUAL CURE ACTIVATOR

GC DUAL CURE ACTIVATOR is a primer to a tooth abutment. It must be used to mix with G-Premio BOND (510(k) No. K143140). All components in GC DUAL CURE ACTIVATOR have been used in previous products such as LINKMAX SELF ETCHING PRIMER (K001823). GC DUAL CURE ACTIVATOR does come in contact with body tissues (tooth - enamel, dentin) for more than 24 hours. . Biological testing results in accordance with ISO 10993-5 show the test article does not have a cytotoxic effect. Testing in accordance with ISO 10993-10, showed 0% sensitization rate, and was considered to be non-irritants to the buccal tissues. Biological testing as well as the similarity of components to the predicate device, the similarity of the principle operation, and the similarity of the performance data, support substantial equivalence.

TRY-IN PASTE

TRY-IN PASTE is a hue-conformity verification material. TRY-IN PASTE does come in contact with body tissues (tooth - enamel, dentin). Furthermore, TRY-IN PASTE does not remain in the oral cavity as outlined in instructions for use. . Biological testing results in accordance with ISO 10993-5 show the test article does not have a cytotoxic effect. Testing in accordance with ISO 10993-10, showed 0% sensitization rate, and was considered to be non-irritants to the buccal tissues. Biological testing results as well as the similarity of components to the predicate device, the similarity of the principle operation, and the similarity of the performance data, support substantial equivalence.

MULTI PRIMER

MULTI PRIMER is a priming agent designed to treat the adherend surface of glass ceramic, hybrid ceramic (e.g. GC Cerasmart), zirconia, alumina, composite and metal restorations to promote a strong bond to resin-based materials as resin-based cements in case of luting procedures or direct composites in case of repairs. Components in MULTI PRIMER have been used in previous products such as CERAMIC PRIMER II (K001823) and METAL PRIMER II (K001823). . Biological testing results in accordance with ISO 10993-5 show the test article does not have a cytotoxic effect. Testing in accordance with ISO 10993-10, showed 0% sensitization rate, and was considered to be non-irritants to the buccal tissues. Biological testing as well as the similarity of components to the predicate device, the similarity of the principle operation, and the similarity of the performance data, support substantial equivalence.

Substantial equivalence: 11.

G-CEM LinkForce

The applicant device, G-CEM LinkForce, complies with all the requirements of ISO 4049: 2009 (Dentistry - Polymer-based restorative materials).

The curing mechanism of the applicant and predicate devices is polymerization of uncured methacrylate ester monomers. The curing mechanism of the applicant and predicate devices is substantially equivalent in principle. The applicant and predicate devices are the same in function, and similar in composition and intended use. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

GC DUAL CURE ACTIVATOR

The applicant device, GC DUAL CURE ACTIVATOR, complies with all the requirements of ISO11405: 2003 (Dental materials - Testing of adhesion to tooth structure).

{11}------------------------------------------------

All the components of the applicant device, GC DUAL CURE ACTIVATOR, have already been used in the reference predicate device. The chemical composition of the applicant device is such that it can also bond to tooth surfaces (like the predicate) as well as composites, hybrid ceramics, and metals. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

TRY-IN PASTE

TRY-IN PASTE is substantially equivalent to the predicate devices in that they are same in function, indications, and application. Furthermore, the applicant device and primary predicate are both glycerol-based in composition. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

MULTI PRIMER

Components in MULTI PRIMER have been used in primary predicate device CERAMIC PRIMER II and reference predicate METAL PRIMER II. The primary and reference predicate cover all indications of applicant device. This supports that the compatibility of the applicant device is substantially equivalent to the predicate devices.

12. Differences

The following differences may be noted between the applicant device and predicate devices:

G-CEM LinkForce

G-Cem Linkforce differs from RelyX Ultimate in terms of radiopacity. This occurs due to difference in glass fillers used in formulation.

GC DUAL CURE ACTIVATOR

GC Dual Cure Activator must always be used with G-Premio Bond (a 2-piece system) while the primary predicate is a single-component system. The applicant device can be used in dark cure mode.

TRY-IN PASTE

TRY-IN PASTE is not indicated to protect the etch pattern during try-in as indicated in the primary predicate. Slight variation of formulation (pigments) of applicant device results in varying shades.

MULTI PRIMER

MULTI PRIMER is a primer to glass ceramic, oxide ceramic, hybrid ceramic, composite and metal restorations but CERAMIC PRIMER II is without metal restoration, and Metal Primer II provides a bond between resin and metal.

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	Applicant device	Comparative device (primary)	Comparative device (reference)
Indications for use	(G-CEM LinkForce)1. Cementation of all types of all ceramic,resin and metal-based inlays, onlays,crowns and bridges.2. Cementation of metal, ceramic, fiberposts, and cast post and cores.3. Cementation of all ceramic andcomposite veneers (up to 2 teeth)4.Permanent cementation of crowns andbridges on implant abutments.	(RelyX Ultimate)1. Final cementing of all-ceramic, composite, ormetal inlays, onlays, crowns and bridges;2-3-unit Maryland bridges and 3-unitinlay/onlay bridges (excluded for patients withbruxism or periodontitis)2. Final cementing of posts and screws3. Final cementation of all-ceramic, orcomposite veneers4. Final cementation of all-ceramic, composite,or metal restorations on implant abutments	(LINKMAX)1. Bonding composite (micro-filled resin (MFR)or hybrid) inlays, onlays, bridges, veneers andcrowns to tooth structure.2. Bonding porcelain crowns, inlays, onlaysand veneers to tooth structure.3. Bonding precious or non-precious metalinlays, onlays, crowns and bridges to toothstructure.
Productdescription	G-CEM LinkForce is a dual-cured resincement. The components consists ofPaste A and B, which are filled in aone-body syringe. Both pastes areautomixed with a mixing tip.	RelyX Ultimate is a dual-curing resin cementsupplied in an automix syringe. It is used forthe adhesive cementation of indirectrestorations and available in various shades.RelyX Ultimate is used in combination withScotchbond Universal Adhesive. The adhesivecan be used either as a "Total Etch" or"Self-Etch" procedure. The additional etchingof the tooth structure with ScotchbondUniversal Etchant increases the adhesivestrength of the adhesive even further. RelyXUltimate contains bi-functional (meth) acrylate.The proportion of inorganic fillers is about 43%by volume; the grain size (D 90%) is about 13um. The mixing ratio, based on volume, is 1part base paste : 1 part catalyst.	LINKMAX is a dual cure composite resindesigned to bond various types of prosthesesto tooth structure. It uses a self-etching primerto bond to tooth structure and separateprimers to bond to prostheses, core build-upsand posts made out of different materials.LINKMAX Paste Pak can be dispensed easilyand accurately using the Paste Pak Dispenser.
Instructions forUse	1.Tooth preparation2. Pre-treatment of the restoration3. Dispensing cement paste4. Cementation5. Excess cement removal6. Final set	1. Trial fitting of the restoration2. Pre-treatment of restorations3. Dosing and applying adhesive4. Application of the cement5. Removal of excess6. Polymerization and shaping	1. Restoration preparation2. Tooth preparation3. Dispensing cement paste4. Mixing cement paste5. Cementation6. Excess cement removal7. Final set

Primary and reference predicate cover all indications of applicant device to predicate device to predicate devices are same in function. Only difference in applicant device to predicate devices are slight change in glass fillers.

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Table 5.7 Comparison of GC DUAL CURE ACTIVATOR to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
Indicationsfor use	(GC DUAL CURE ACTIVATOR)1. Cementation of indirect restorations.2. Bonding of core build-ups made oflight-curing composite or core build-upmaterials to tooth structure.3. Bonding of resin cements and corebuild-up materials and self-curecomposites to tooth structure.	(Scotchbond Universal)1. All classes of fillings (according to Black) with light-curingcomposite or compomer filling materials2. Cementation of indirect restorations when combined withRelyX Ultimate Adhesive Resin Cement3. Cementation of veneers when combined with RelyX VeneerCement4. Bonding of core build-ups made of light-curing composite orcore build-up materials5. Bonding of dual-cure cements and core build-up materialsand self-cure composites when combined with ScotchbondUniversal DCA6. Repair of composite or compomer fillings7. Intraoral repair of composite restorations, porcelain fused tometal, and all-ceramic restorations without extra primer8. Root surface desensitization9. Sealing of cavities prior to cementation of amalgamrestorations10. Sealing of cavities and preparation of tooth stumps prior totemporary cementation of indirect restorations11. Bonding of fissure sealants12. Protective varnish for glass ionomer fillings	(LINKMAX Self-Etching Primer A & B)1. Bonding composite (micro-filled resin (MFR) orhybrid) inlays, onlays, bridges, veneers andcrowns to tooth structure.2. Bonding porcelain crowns, inlays, onlays andveneers to tooth structure.3. Bonding precious or non-precious metal inlays,onlays, crowns and bridges to tooth structure.
Productdescription	GC DUAL CURE ACTIVATOR is aprimer to a tooth abutment. It must beused to mix with G-Premio BOND.	Scotchbond Universal is a single-component, light-curingadhesive which is available in L-Pop blisters for single dosingor in bottles for multiple doses.	Self-etching Primers are materials which areapplied to dentin and enamel to enhance theadhesion of the tooth.
Instructionsfor Use	1.Tooth preparation2. Pre-treatment of the restoration3. Dispensing cement paste4. Cementation5. Excess cement removal	1. Trial fitting of the restoration2. Pre-treatment of restorations3. Dosing and applying adhesive4. Application of the cement5. Removal of excess	1. Restoration preparation2. Tooth preparation3. Dispensing cement paste4. Mixing cement paste5. Cementation
	6. Final set	6. Polymerization and shaping	6. Excess cement removal7. Final set

Primary and reference predicate cover all indications of applicant device. GC DUAL CURE ACTIVATOR is part of a 2-piece system and must be mixed with G-Premio Bond, while the primary predicate is a single-component.

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Table 5.8 Comparison of TRY-IN PASTE to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
Indicationsfor use	(TRY-IN PASTE)To evaluate the shade and the fitting ofthe restoration prior to permanentcementation.	(Variolink Veneer Try-In)Simulation of the shade of the permanent luting composite.Assessment of the accuracy of fit of the final restoration.Protection of the etch pattern during try-in, in case etching ofthe ceramic was performed in the laboratory.	(RelyX TRY-IN Paste)Color matching guide for RelyX Veneercement.
Productdescription	TRY-IN PASTE is a hue-conformityverification material.	Variolink Veneer Try-In are based on the true influences ofthe cement on the esthetics of final restoration, rather thanon the 'color' of the cement.	RelyX™ Try-In Paste are used to guide thedentist in the selection of the shade requiredfor the final cementation.
Instructionsfor Use	1. Prepare tooth2. Dispense Try-in Paste onto internalsurface of restoration.3. Check fit and aesthetics of restoration.4. Remove restoration.5. Rinse out Try-in Paste	1. Prepare tooth2. Dispense Try-in Paste onto internal surface of restoration.3. Check fit and aesthetics of restoration.4. Remove restoration.5. Rinse out Try-in Paste	1. Prepare tooth2. Dispense Try-in Paste onto internal surfaceof restoration.3. Check fit and aesthetics of restoration.4. Remove restoration.5. Rinse out Try-in Paste

The primary predicate covers all the indicant device and is the same in function and application. The application. The applicant and primary predicate are glycerol-based in composition.

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Table 5.9 Comparison of MULTI PRIMER to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
Indicationsfor use	(MULTI PRIMER)1. Priming of the adherend surfaces of indirectrestorations made of glass ceramics, oxideceramics, hybrid ceramics, composite and metalbefore luting procedures.2. Intra-oral and extra-oral repair of fracturedindirect restorations made of ceramics, hybridceramics and composites.	(CERAMIC PRIMER II)1. Treatment of ceramic prosthesis withphosphoric acid etchant.	(Metal Primer II)1. resin cement to metal for metal inlays, crownsand bridges2. opaque resin to metal for composite resinveneers and crowns3. denture base to magnetic attachment4. denture base resin to metal base, clasp orattachment5. in-mouth repair of damaged crown and bridgeveneers6. repair of denture with metal base, clasp orattachment7. bonding resin to metal orthodontic appliances
Productdescription	MULTI PRIMER is a priming agent designed totreat the adherend surface of glass ceramic,oxide ceramic, hybrid ceramic, composite andmetal restorations to promote a strong bond toresin-based materials as resin-based cements incase of luting procedures or direct composites incase of repairs.	CERAMIC PRIMER II is a priming agentdesigned to firmly bond ceramic prostheses totooth structure using resin adhesive cement.	METAL PRIMER II is a metal surface treatmentmaterial which provides a bond between the resinand metal in fabricating dental appliances such asbonding opaque material to metal framework forhard resin veneer crowns, bonding denture baseresin to metal base, clasp, attachment, repair ofdenture and bonding orthodontic resin to metalorthodontic bracket and wire.
Instructionsfor Use	1. Preparation2. Application	1. Preparation2. Application	1. Preparation2. Application

The applicant device can adhere to ceramic and whereas the primary predicate can adhere only to ceramic and the reference predicate can adhere only to metal. Primary and reference predicate cover all indications of applicant device.

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13. Conclusion

G-CEM LinkForce

Based on similarities in intended use, mode of action, chemical composition, and performance testing, G-CEM LinkForce, is substantially equivalent to the primary predicate device RelyX Ultimate (K110508) and reference predicate device LinkMax (K001823).

GC DUAL CURE ACTIVATOR

Based on similarities in intended use, mode of action, chemical composition, and performance testing, GC DUAL CURE ACTIVATOR is substantially equivalent to the primary predicate device Scotchbond Universal (K110302), and reference predicate device LinkMax Self-Etching Primer B (K001823).

TRY-IN PASTE

Based on similarities in intended use, mode of action, chemical composition, and performance testing, TRY-IN PASTE is substantially equivalent to the primary predicate device Variolink Veneer Try-In (K931309), and reference predicate device RelyX Try-In Paste (K002452).

MULTI PRIMER

Based on similarities in intended use, mode of action, chemical composition, and performance testing, MULTI PRIMER is substantially equivalent to the primary predicate device Ceramic Primer II (K001823) and reference predicate device Metal Primer II (K972594).

Regulation Number and Section

§ 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.