Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The 510(k) summary describes a dental cement system and related materials. There is no mention of AI or ML in the intended use, device description, or performance studies. The device functions as a chemical bonding agent and related accessories.

Therapeutic

No
The device is a dental cement system used for bonding and repairing dental restorations, which is not considered a therapeutic device as it does not treat or cure a disease.

Diagnostic

No

Explanation: The devices described are dental materials (cements, activators, try-in pastes, primers) used for bonding, cementation, and evaluating fit and shade of dental restorations. None of their stated intended uses or functions involve diagnosing a medical condition or disease.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components (pastes, syringes, mixing tips, primers) and their chemical properties and functions, indicating it is a physical medical device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended uses described for G-CEM LinkForce, GC DUAL CURE ACTIVATOR, TRY-IN PASTE, and MULTI PRIMER are all related to the cementation, bonding, and preparation of dental restorations and tooth structure. These are procedures performed directly on or in the patient's mouth for therapeutic or restorative purposes.
Device Description: The device descriptions confirm that these are materials used in dental procedures (resin cement, primer, try-in paste, priming agent).
Lack of In Vitro Diagnostic Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or screening.

IVD devices are specifically designed to perform tests on biological samples in vitro (outside the living organism). This device is used in vivo (within the living organism) for dental restoration procedures.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

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.

Product codes (comma separated list FDA assigned to the subject device)

EMA, KLE, EBF

Device Description

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 is available in 4 shades: Translucent, A2, Opaque, Bleach.
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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Tooth (enamel, dentin), implant abutments

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Performance Bench Tests:

Standard: ISO 4049: 2009 (Dentistry Polymer-based restorative materials) for G-CEM LinkForce.
- Properties tested: Appearance, Film thickness, Working time, Setting time, Depth of cure, Flexural strength, Water sorption, solubility, Radiopacity.
- Requirements: Film thickness (No greater than 50 µm), Working time (No detectable change in its homogeneity), Setting time (Not more than 10 min), Depth of cure (Opaque shade: not less than 0.5 mm; Other shade: not less than 1.5 mm), Flexural strength (Greater than 50 MPa), Water sorption (Less than 40 µg/mm), Solubility (Less than 7.5 µg/mm), Radiopacity (Greater than the same thickness of aluminum).
Standard: ISO11405: 2015 (Dental materials Testing of adhesion to tooth structure) for G-Premio BOND with GC DUAL CURE ACTIVATOR.
- Properties tested: Adhesion to Dentin, Adhesion to Enamel.
- Requirements: Tensile bond strength to bovine dentin (Greater than 5MPa), Tensile bond strength to bovine enamel (Greater than 9MPa).
Internal Company Test Method for TRY-IN PASTE and MULTI PRIMER.
- TRY-IN PASTE: Film thickness (No greater than 50 µm).
- MULTI PRIMER: Tensile bond strength to porcelain (Greater than 10MPa), Tensile bond strength to zirconia (Greater than 10MPa), Tensile bond strength to Au-Ag-Pd alloy (Greater than 10MPa).

Biocompatibility:

G-CEM LinkForce: 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.
GC DUAL CURE ACTIVATOR: 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.
TRY-IN PASTE: 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.
MULTI PRIMER: 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.

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

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.

K110508, K110302, K931309, K001823

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.

K001823, K002452, K972594

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

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.

Summary

0

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.

1

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

2

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 Primer
A 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

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 is available in 4 shades: Translucent, A2, Opaque, Bleach.

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

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.

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MULTI PRIMER

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.

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 mm
Other 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.

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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).

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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)

Cementation of all types of all ceramic,
resin and metal-based inlays, onlays,
crowns and bridges.
Cementation of metal, ceramic, fiber
posts, and cast post and cores.
Cementation of all ceramic and
composite veneers (up to 2 teeth)
4.Permanent cementation of crowns and
bridges on implant abutments. | (RelyX Ultimate)
Final cementing of all-ceramic, composite, or
metal inlays, onlays, crowns and bridges;
2-3-unit Maryland bridges and 3-unit
inlay/onlay bridges (excluded for patients with
bruxism or periodontitis)
Final cementing of posts and screws
Final cementation of all-ceramic, or
composite veneers
Final cementation of all-ceramic, composite,
or metal restorations on implant abutments | (LINKMAX)
Bonding composite (micro-filled resin (MFR)
or hybrid) inlays, onlays, bridges, veneers and
crowns to tooth structure.
Bonding porcelain crowns, inlays, onlays
and veneers to tooth structure.
Bonding precious or non-precious metal
inlays, onlays, crowns and bridges to tooth
structure. |
| Product
description | 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. | RelyX Ultimate is a dual-curing resin cement
supplied in an automix syringe. It is used for
the adhesive cementation of indirect
restorations and available in various shades.
RelyX Ultimate is used in combination with
Scotchbond Universal Adhesive. The adhesive
can be used either as a "Total Etch" or
"Self-Etch" procedure. The additional etching
of the tooth structure with Scotchbond
Universal Etchant increases the adhesive
strength of the adhesive even further. RelyX
Ultimate contains bi-functional (meth) acrylate.
The proportion of inorganic fillers is about 43%
by volume; the grain size (D 90%) is about 13
um. The mixing ratio, based on volume, is 1
part base paste : 1 part catalyst. | LINKMAX is a dual cure composite resin
designed to bond various types of prostheses
to tooth structure. It uses a self-etching primer
to bond to tooth structure and separate
primers to bond to prostheses, core build-ups
and posts made out of different materials.
LINKMAX Paste Pak can be dispensed easily
and accurately using the Paste Pak Dispenser. |
| Instructions for
Use | 1.Tooth preparation
Pre-treatment of the restoration
Dispensing cement paste
Cementation
Excess cement removal
Final set | 1. Trial fitting of the restoration
Pre-treatment of restorations
Dosing and applying adhesive
Application of the cement
Removal of excess
Polymerization and shaping | 1. Restoration preparation
Tooth preparation
Dispensing cement paste
Mixing cement paste
Cementation
Excess cement removal
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.

13

Table 5.7 Comparison of GC DUAL CURE ACTIVATOR to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
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. | (Scotchbond Universal)
All classes of fillings (according to Black) with light-curing
composite or compomer filling materials
Cementation of indirect restorations when combined with
RelyX Ultimate Adhesive Resin Cement
Cementation of veneers when combined with RelyX Veneer
Cement
Bonding of core build-ups made of light-curing composite or
core build-up materials
Bonding of dual-cure cements and core build-up materials
and self-cure composites when combined with Scotchbond
Universal DCA
Repair of composite or compomer fillings
Intraoral repair of composite restorations, porcelain fused to
metal, and all-ceramic restorations without extra primer
Root surface desensitization
Sealing of cavities prior to cementation of amalgam
restorations
Sealing of cavities and preparation of tooth stumps prior to
temporary cementation of indirect restorations
Bonding of fissure sealants
Protective varnish for glass ionomer fillings | (LINKMAX Self-Etching Primer A & B)
Bonding composite (micro-filled resin (MFR) or
hybrid) inlays, onlays, bridges, veneers and
crowns to tooth structure.
Bonding porcelain crowns, inlays, onlays and
veneers to tooth structure.
Bonding precious or non-precious metal inlays,
onlays, crowns and bridges to tooth structure. |
| Product
description | GC DUAL CURE ACTIVATOR is a
primer to a tooth abutment. It must be
used to mix with G-Premio BOND. | Scotchbond Universal is a single-component, light-curing
adhesive which is available in L-Pop blisters for single dosing
or in bottles for multiple doses. | Self-etching Primers are materials which are
applied to dentin and enamel to enhance the
adhesion of the tooth. |
| Instructions
for Use | 1.Tooth preparation
Pre-treatment of the restoration
Dispensing cement paste
Cementation
Excess cement removal | 1. Trial fitting of the restoration
Pre-treatment of restorations
Dosing and applying adhesive
Application of the cement
Removal of excess | 1. Restoration preparation
Tooth preparation
Dispensing cement paste
Mixing cement paste
Cementation |
| | 6. Final set | 6. Polymerization and shaping | 6. Excess cement removal
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.

14

Table 5.8 Comparison of TRY-IN PASTE to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
Indications
for use	(TRY-IN PASTE)
To evaluate the shade and the fitting of
the restoration prior to permanent
cementation.	(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 of
the ceramic was performed in the laboratory.	(RelyX TRY-IN Paste)
Color matching guide for RelyX Veneer
cement.
Product
description	TRY-IN PASTE is a hue-conformity
verification material.	Variolink Veneer Try-In are based on the true influences of
the cement on the esthetics of final restoration, rather than
on the 'color' of the cement.	RelyX™ Try-In Paste are used to guide the
dentist in the selection of the shade required
for the final cementation.
Instructions
for Use	1. Prepare tooth

Dispense Try-in Paste onto internal
surface of restoration.
Check fit and aesthetics of restoration.
Remove restoration.
Rinse out Try-in Paste | 1. Prepare tooth
Dispense Try-in Paste onto internal surface of restoration.
Check fit and aesthetics of restoration.
Remove restoration.
Rinse out Try-in Paste | 1. Prepare tooth
Dispense Try-in Paste onto internal surface
of restoration.
Check fit and aesthetics of restoration.
Remove restoration.
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.

15

Table 5.9 Comparison of MULTI PRIMER to predicate device
	Applicant device	Comparative device (primary)	Comparative device (reference)
Indications
for use	(MULTI PRIMER)

Priming of the adherend surfaces of indirect
restorations made of glass ceramics, oxide
ceramics, hybrid ceramics, composite and metal
before luting procedures.
Intra-oral and extra-oral repair of fractured
indirect restorations made of ceramics, hybrid
ceramics and composites. | (CERAMIC PRIMER II)
Treatment of ceramic prosthesis with
phosphoric acid etchant. | (Metal Primer II)
resin cement to metal for metal inlays, crowns
and bridges
opaque resin to metal for composite resin
veneers and crowns
denture base to magnetic attachment
denture base resin to metal base, clasp or
attachment
in-mouth repair of damaged crown and bridge
veneers
repair of denture with metal base, clasp or
attachment
bonding resin to metal orthodontic appliances | | |
| Product
description | 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. | CERAMIC PRIMER II is a priming agent
designed to firmly bond ceramic prostheses to
tooth structure using resin adhesive cement. | METAL PRIMER II is a metal surface treatment
material which provides a bond between the resin
and metal in fabricating dental appliances such as
bonding opaque material to metal framework for
hard resin veneer crowns, bonding denture base
resin to metal base, clasp, attachment, repair of
denture and bonding orthodontic resin to metal
orthodontic bracket and wire. | | |
| Instructions
for Use | 1. Preparation
Application | 1. Preparation
Application | 1. Preparation
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.

16

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).