G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

{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. - 2. Cementation of metal, ceramic, fiber posts, and cast post and cores. - 3. Cementation of all ceramic and composite veneers (up to 2 teeth) - 4. 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) {3}------------------------------------------------ 510(k) Number: K153231 Device Name: GC DUAL CURE ACTIVATOR Indications for Use: GC DUAL CURE ACTIVATOR 1. Cementation of indirect restorations. 2. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure. 3. 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 {4}------------------------------------------------ 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) {5}------------------------------------------------ 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. - 2. 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) {6}------------------------------------------------ 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<br>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. {7}------------------------------------------------ ### 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. - 2. Cementation of metal, ceramic, fiber posts, and cast post and cores. - 3. 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. - 2. Bonding of core build-ups made of light-curing composite or core build-up materials to tooth structure. - 3. 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. - 2. 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. - 7. 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 - 2. 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<br>- Film thickness<br>- Working time<br>- Setting time<br>- Depth of cure<br>- Flexural strength<br>- Water sorption<br>- solubility<br>- Radiopacity | - Adhesion to Dentin<br>- Adhesion to Enamel | ### Table 5.1 Performance testing properties {9}------------------------------------------------ | 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<br>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. {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. {12}------------------------------------------------ | | Applicant device | Comparative device (primary) | Comparative device (reference) | |-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for use | (G-CEM LinkForce)<br>1. Cementation of all types of all ceramic,<br>resin and metal-based inlays, onlays,<br>crowns and bridges.<br>2. Cementation of metal, ceramic, fiber<br>posts, and cast post and cores.<br>3. Cementation of all ceramic and<br>composite veneers (up to 2 teeth)<br>4.Permanent cementation of crowns and<br>bridges on implant abutments. | (RelyX Ultimate)<br>1. Final cementing of all-ceramic, composite, or<br>metal inlays, onlays, crowns and bridges;<br>2-3-unit Maryland bridges and 3-unit<br>inlay/onlay bridges (excluded for patients with<br>bruxism or periodontitis)<br>2. Final cementing of posts and screws<br>3. Final cementation of all-ceramic, or<br>composite veneers<br>4. Final cementation of all-ceramic, composite,<br>or metal restorations on implant abutments | (LINKMAX)<br>1. Bonding composite (micro-filled resin (MFR)<br>or hybrid) inlays, onlays, bridges, veneers and<br>crowns to tooth structure.<br>2. Bonding porcelain crowns, inlays, onlays<br>and veneers to tooth structure.<br>3. Bonding precious or non-precious metal<br>inlays, onlays, crowns and bridges to tooth<br>structure. | | Product<br>description | G-CEM LinkForce is a dual-cured resin<br>cement. The components consists of<br>Paste A and B, which are filled in a<br>one-body syringe. Both pastes are<br>automixed with a mixing tip. | RelyX Ultimate is a dual-curing resin cement<br>supplied in an automix syringe. It is used for<br>the adhesive cementation of indirect<br>restorations and available in various shades.<br>RelyX Ultimate is used in combination with<br>Scotchbond Universal Adhesive. The adhesive<br>can be used either as a "Total Etch" or<br>"Self-Etch" procedure. The additional etching<br>of the tooth structure with Scotchbond<br>Universal Etchant increases the adhesive<br>strength of the adhesive even further. RelyX<br>Ultimate contains bi-functional (meth) acrylate.<br>The proportion of inorganic fillers is about 43%<br>by volume; the grain size (D 90%) is about 13<br>um. The mixing ratio, based on volume, is 1<br>part base paste : 1 part catalyst. | LINKMAX is a dual cure composite resin<br>designed to bond various types of prostheses<br>to tooth structure. It uses a self-etching primer<br>to bond to tooth structure and separate<br>primers to bond to prostheses, core build-ups<br>and posts made out of different materials.<br>LINKMAX Paste Pak can be dispensed easily<br>and accurately using the Paste Pak Dispenser. | | Instructions for<br>Use | 1.Tooth preparation<br>2. Pre-treatment of the restoration<br>3. Dispensing cement paste<br>4. Cementation<br>5. Excess cement removal<br>6. Final set | 1. Trial fitting of the restoration<br>2. Pre-treatment of restorations<br>3. Dosing and applying adhesive<br>4. Application of the cement<br>5. Removal of excess<br>6. Polymerization and shaping | 1. Restoration preparation<br>2. Tooth preparation<br>3. Dispensing cement paste<br>4. Mixing cement paste<br>5. Cementation<br>6. Excess cement removal<br>7. 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<br>for use | (GC DUAL CURE ACTIVATOR)<br>1. Cementation of indirect restorations.<br>2. Bonding of core build-ups made of<br>light-curing composite or core build-up<br>materials to tooth structure.<br>3. Bonding of resin cements and core<br>build-up materials and self-cure<br>composites to tooth structure. | (Scotchbond Universal)<br>1. All classes of fillings (according to Black) with light-curing<br>composite or compomer filling materials<br>2. Cementation of indirect restorations when combined with<br>RelyX Ultimate Adhesive Resin Cement<br>3. Cementation of veneers when combined with RelyX Veneer<br>Cement<br>4. Bonding of core build-ups made of light-curing composite or<br>core build-up materials<br>5. Bonding of dual-cure cements and core build-up materials<br>and self-cure composites when combined with Scotchbond<br>Universal DCA<br>6. Repair of composite or compomer fillings<br>7. Intraoral repair of composite restorations, porcelain fused to<br>metal, and all-ceramic restorations without extra primer<br>8. Root surface desensitization<br>9. Sealing of cavities prior to cementation of amalgam<br>restorations<br>10. Sealing of cavities and preparation of tooth stumps prior to<br>temporary cementation of indirect restorations<br>11. Bonding of fissure sealants<br>12. Protective varnish for glass ionomer fillings | (LINKMAX Self-Etching Primer A & B)<br>1. Bonding composite (micro-filled resin (MFR) or<br>hybrid) inlays, onlays, bridges, veneers and<br>crowns to tooth structure.<br>2. Bonding porcelain crowns, inlays, onlays and<br>veneers to tooth structure.<br>3. Bonding precious or non-precious metal inlays,<br>onlays, crowns and bridges to tooth structure. | | Product<br>description | GC DUAL CURE ACTIVATOR is a<br>primer to a tooth abutment. It must be<br>used to mix with G-Premio BOND. | Scotchbond Universal is a single-component, light-curing<br>adhesive which is available in L-Pop blisters for single dosing<br>or in bottles for multiple doses. | Self-etching Primers are materials which are<br>applied to dentin and enamel to enhance the<br>adhesion of the tooth. | | Instructions<br>for Use | 1.Tooth preparation<br>2. Pre-treatment of the restoration<br>3. Dispensing cement paste<br>4. Cementation<br>5. Excess cement removal | 1. Trial fitting of the restoration<br>2. Pre-treatment of restorations<br>3. Dosing and applying adhesive<br>4. Application of the cement<br>5. Removal of excess | 1. Restoration preparation<br>2. Tooth preparation<br>3. Dispensing cement paste<br>4. Mixing cement paste<br>5. Cementation | | | 6. Final set | 6. Polymerization and shaping | 6. Excess cement removal<br>7. 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<br>for use | (TRY-IN PASTE)<br>To evaluate the shade and the fitting of<br>the restoration prior to permanent<br>cementation. | (Variolink Veneer Try-In)<br>Simulation of the shade of the permanent luting composite.<br>Assessment of the accuracy of fit of the final restoration.<br>Protection of the etch pattern during try-in, in case etching of<br>the ceramic was performed in the laboratory. | (RelyX TRY-IN Paste)<br>Color matching guide for RelyX Veneer<br>cement. | | Product<br>description | TRY-IN PASTE is a hue-conformity<br>verification material. | Variolink Veneer Try-In are based on the true influences of<br>the cement on the esthetics of final restoration, rather than<br>on the 'color' of the cement. | RelyX™ Try-In Paste are used to guide the<br>dentist in the selection of the shade required<br>for the final cementation. | | Instructions<br>for Use | 1. Prepare tooth<br>2. Dispense Try-in Paste onto internal<br>surface of restoration.<br>3. Check fit and aesthetics of restoration.<br>4. Remove restoration.<br>5. Rinse out Try-in Paste | 1. Prepare tooth<br>2. Dispense Try-in Paste onto internal surface of restoration.<br>3. Check fit and aesthetics of restoration.<br>4. Remove restoration.<br>5. Rinse out Try-in Paste | 1. Prepare tooth<br>2. Dispense Try-in Paste onto internal surface<br>of restoration.<br>3. Check fit and aesthetics of restoration.<br>4. Remove restoration.<br>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. {15}------------------------------------------------ | Table 5.9 Comparison of MULTI PRIMER to predicate device | | | | | | |----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--| | | Applicant device | Comparative device (primary) | Comparative device (reference) | | | | Indications<br>for use | (MULTI PRIMER)<br>1. Priming of the adherend surfaces of indirect<br>restorations made of glass ceramics, oxide<br>ceramics, hybrid ceramics, composite and metal<br>before luting procedures.<br>2. Intra-oral and extra-oral repair of fractured<br>indirect restorations made of ceramics, hybrid<br>ceramics and composites. | (CERAMIC PRIMER II)<br>1. Treatment of ceramic prosthesis with<br>phosphoric acid etchant. | (Metal Primer II)<br>1. resin cement to metal for metal inlays, crowns<br>and bridges<br>2. opaque resin to metal for composite resin<br>veneers and crowns<br>3. denture base to magnetic attachment<br>4. denture base resin to metal base, clasp or<br>attachment<br>5. in-mouth repair of damaged crown and bridge<br>veneers<br>6. repair of denture with metal base, clasp or<br>attachment<br>7. bonding resin to metal orthodontic appliances | | | | Product<br>description | MULTI PRIMER is a priming agent designed to<br>treat the adherend surface of glass ceramic,<br>oxide ceramic, hybrid ceramic, composite and<br>metal restorations to promote a strong bond to<br>resin-based materials as resin-based cements in<br>case of luting procedures or direct composites in<br>case of repairs. | CERAMIC PRIMER II is a priming agent<br>designed to firmly bond ceramic prostheses to<br>tooth structure using resin adhesive cement. | METAL PRIMER II is a metal surface treatment<br>material which provides a bond between the resin<br>and metal in fabricating dental appliances such as<br>bonding opaque material to metal framework for<br>hard resin veneer crowns, bonding denture base<br>resin to metal base, clasp, attachment, repair of<br>denture and bonding orthodontic resin to metal<br>orthodontic bracket and wire. | | | | Instructions<br>for Use | 1. Preparation<br>2. Application | 1. Preparation<br>2. Application | 1. Preparation<br>2. 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).